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EXHIBIT 10.3(d)
FOURTH AMENDMENT TO AGREEMENT
This Fourth Amendment to Agreement ("Fourth Amendment") is made by and
between Atrix Laboratories, Inc., a Delaware Corporation ("Atrix"). with its
principal place of business at 0000 Xxxxxxxx Xxxxx, Xxxx Xxxxxxx, Xxxxxxxx
00000-0000; and Block Drug Corporation, a New Jersey corporation ("Block"), with
its principal place of business at 000 Xxxxxxx Xxxxxx, Xxxxxx Xxxx, Xxx Xxxxxx
00000-0000, is made and effective as of this 12th day of January, 1999, with
respect to that certain Agreement dated as of December 16, 1996 (the
"Agreement"), between Atrix and Block, as amended by that certain First
Amendment to Agreement dated as of June 10, 1997, by that certain Second
Amendment to Agreement dated as of July 31, 1997, and further amended by that
certain Third Amendment to Agreement dated February 4, 1998.
WHEREAS, the parties desire to further amend the Agreement on the terms
and conditions set forth herein.
NOW THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereto hereby amend
the Agreement as follows:
1. The definition of "ATRISORB with Doxycycline" in Article I is deleted and
the following definition inserted in lieu thereof:
"ATRISORB with Doxycycline" means the Atrisorb barrier containing
doxycycline, [**].
2. Section 3.02 is hereby deleted and the following language shall be inserted
in lieu thereof:
Section 3.02(b) Atrisorb(R) with Doxycycline Milestone
Payments. In the event the FDA issues a Clearance Letter for
the [**] Atrisorb(R) with Doxycycline, Atrix shall be entitled
to receive from Block additional milestone payments upon the
following terms and conditions:
(i) A one time milestone payment of [**], which shall be
payable within thirty (30) days following receipt by
Block of Notice from Atrix that the FDA has issued a
Clearance Letter for the [**] Atrisorb(R) with
Doxycycline; and
(ii) provided the FDA has issued the Clearance Letter for
the [**] Atrisorb(R) with Doxycycline prior to April
1, 2000, a one time milestone payment of [**] which
shall be payable within ninety (90) days after the
receipt by Block of Notice from Atrix that the FDA
has issued a Clearance Letter for the [**]
Atrisorb(R) with Doxycycline; but
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** Confidential Treatment Requested by Atrix on March 23, 1999
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(iii) in the event the FDA has not issued the Clearance
Letter for the [**] Atrisorb(R) with Doxycycline
prior to April 2, 2000, a one time milestone payment
of [**] which shall be payable within ten (10) days
after the close of the calendar quarter in which
Block makes the First Commercial Sale of the [**]
Atrisorb(R) with Doxycycline in the United States.
3. Section 14.09(b) is hereby deleted and the following language shall be
inserted in lieu thereof:
(b) Any topical or mucosal therapy product that is intended to treat the signs
and symptoms of periodontal disease, provided however that the prohibition set
forth in this subsection shall expire at midnight, eastern standard time, on
[**], and further provided that nothing in this section shall be construed to
prohibit Block from conducting business in (i) any treatment or any therapy
primarily indicated for the signs and symptoms of gingivitis or (ii) Block's
[**] product, provided that in no event shall Block promote any such treatment
or therapy for the treatment of periodontitis.
4. Article XIV is hereby amended by adding section 14.12, which reads as
follows:
Section 14.12 Atridox Adverse Drug Events (ADEs). From the Effective Date of
this Amendment through midnight, eastern standard time, on [**], Block shall, at
Block's [**], be responsible for that portion of ADE data collection activity
that occurs between Block and the patient or dental professional, as
appropriate, including any follow-up inquires which Block deems necessary or
appropriate. Block shall handle Atridox ADEs in accordance with Block's policies
and procedures concerning ADEs, as Block in its sole discretion may amend from
time to time provided that such policies and procedures are sufficient, and will
be sufficient if and when amended, for Atrix to perform its obligations to the
FDA regarding ADEs. Promptly upon the execution of this Amendment, Block shall
provide Atrix with a copy of its policies and procedures concerning ADEs and
shall notify Atrix of and deliver copies to Atrix of any amendments to such
policies and procedures. Block shall on a timely basis forward to Atrix that ADE
information required by Atrix to fulfil Atrix's reporting obligations to the FDA
as the holder of the NDA. [**].
5. All capitalized terms used and not otherwise defined herein shall have the
same meanings as set forth in the Agreement.
6. Except as expressly modified by the terms hereof, the terms and provisions
of the Agreement, as amended by the First, Second and Third Amendments,
shall remain in full force and effect as originally written.
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** Confidential Treatment Requested by Atrix on March 23, 1999
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7. Signatures on this Fourth Amendment may be communicated by facsimile
transmission and shall be binding upon the parties transmitting the same by
facsimile transmission. Counterparts with original signatures shall be provided
to the other party within five (5) days of the applicable facsimile
transmission; provided, however, that failure to provide the original
counterpart shall have no affect on the validity or binding nature of this
Fourth Amendment. If executed in counterparts, this Fourth Amendment will be as
effective as if simultaneously executed.
IN WITNESS WHEREOF, the parties hereto have executed this Fourth
Amendment as of the date first written above.
ATRIX LABORATORIES, INC. BLOCK DRUG CORPORATION
By: /s/ Xxxx X. Xxxxxx By: /s/ Xxxxx X. Xxxx
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Xxxx X. Xxxxxx, Vice Chairman Xxxxx X. Xxxx
and Chief Executive Officer President, U.S. Division
