1
EXHIBIT 2.2
Confidential material omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote such omissions.
ADDENDUM TO ASSET PURCHASE AGREEMENT
------------------------------------
Addendum made as of July 10, 1997 to Asset Purchase Agreement made as
of the 25th day of March, 1997 (the "Agreement") between Ascent Pediatrics,
Inc., a Delaware corporation with its principal office at 000 Xxxxxxxxxxx
Xxxxxx, Xxxxx X000, Xxxxxxxxxx, Xxxxxxxxxxxxx 00000 (the "Buyer"), and
Xxxxxx-Xxxxx Laboratories, Inc., a Minnesota corporation with its principal
office at 00000 00xx Xxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxxxx 00000 (the "Seller").
Preliminary Statement
---------------------
The Seller has received from the United States Food and Drug
Administration ("FDA") deficiency letters dated ******************** to
********************** submitted related to ***** to ********** and to changes
being effected by ***** which extended the ********* ********* to *******
strength. The FDA has taken the positions that (i) the previously approved
************ for the ********* ******* would need to be revised to be **
********** with the ********* ***** ********* for *******************
****************************** ************ for ************************** as
proposed and existing as of ************ (the "*********"), (ii) ***************
matters for the ********* ************ would be determined after the FDA
completes its review of the ************** ********************* and (iii) the
******************* is subject to FDA review (collectively, the "FDA Issues").
Seller has taken the position with the FDA that ******** for the *********
************ has previously been approved and complies with FDA regulations,
that the ************ for the ********* ************ previously approved should
be permitted under FDA regulations, and that the ********* ********* is properly
being used by Seller.
NOW, THEREFORE, in consideration of the mutual promises hereinafter set
forth and other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the parties hereby agree as follows:
1. HANDLING OF FDA ISSUES.
The ******, as the ****** of the ********* ********* and certain Assets
of Seller relating thereto pursuant to the Agreement, shall have *******
**************, for a period of ********* from the Closing Date (the "******
******* Period"), for the ******** to ****** the FDA Issues and **************
with the FDA relating thereto, and ***** shall have ******************** with
respect to the development of such ******** and ************** with the FDA.
Specifically, the ******** for ******** the FDA Issues shall be developed
******* by the **************** of the ********************, with the
participation of ****************************** of
-1-
2
Confidential material omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote such omissions.
Washington D.C., who shall be retained as *************** for the *************
****** in connection with the FDA Issues. All written communications with
respect to the FDA Issues shall be subject to ********************* by the *****
**************, and the ****** shall permit the ***** to ************** any
other communications and meetings with the FDA with respect to the FDA issues.
In addition, the ****** undertakes to keep ***** informed on a prompt and timely
basis of any communications or other developments relating to the FDA Issues. In
the event of a ********** between the ***** and the ****** with respect to any
aspect of such ************************************, such ********** shall be
resolved by reference to the recommendation of ******************** of ******
*********************** in the matter. ********* the ************** Period,
***** shall have ******************* with respect to such matters.
2. INDEMNIFICATION.
Buyer agrees that it will not seek indemnification from Seller pursuant
to Section 9 of the Agreement for any Losses incurred by Buyer resulting from
requirements that the *************** for the ********* ************ comply with
the ********* (whether as a result of acceptance by Buyer and Seller of FDA
requirements in such respect, or by order of the FDA or otherwise) or resulting
from any resolution of the FDA Issues specified in clauses (i) and (ii) of the
second sentence of the Preliminary Statement, which is more favorable than the
FDA's present position regarding compliance with the *********. Except as
provided in the immediately preceding sentence, Seller shall indemnify Buyer
pursuant to Section 9 of the Agreement, subject to all of the terms and
conditions thereto, with respect to any Loss incurred by the Buyer arising out
of or in connection with the FDA Issues including, without limitation, Losses
resulting from removal of the *************************** ******* from the
market as a consequence of FDA regulatory action taken in connection with the
FDA Issues. Nothing in this Addendum shall be deemed to expand the Seller's
obligation to indemnify the Buyer beyond such obligation otherwise required by
Section 9 of the Agreement, or except as specifically provided, to limit the
Buyer's rights to indemnification pursuant to Section 9 of the Agreement.
3. EXPENSES.
Notwithstanding the provisions of paragraph 2 above, the fees and
expenses of ****************************** and of any other consultants or
experts retained by agreement of the Seller and the Buyer in connection with the
FDA Issues shall be shared equally by the Buyer and the Seller.
Except as specifically amended herein, the Agreement shall remain in
full force and effect.
-2-
3
IN WITNESS WHEREOF, this Addendum has been duly executed by the parties
hereto as of and on the date first above written.
XXXXXX-XXXXX LABORATORIES, INC.
By: /s/ XXXX X. XXXXX
--------------------------------------------
Title: President and Chief Operating Officer
ASCENT PEDIATRICS, INC.
By: /s/ XXXX X. XXX
--------------------------------------------
Title: President and Chief Executive Officer
-3-
