Sample Business Contracts


Asset Purchase Agreement [Amendment No. 1] - AstraZeneca AB and aaiPharma LLC

Asset Purchase Forms


                   FIRST AMENDMENT TO ASSET PURCHASE AGREEMENT

This FIRST AMENDMENT TO ASSET PURCHASE AGREEMENT (the "Amendment") is made this
22nd day of July 2003, with an effective date as of December 31, 2002, by and
between ASTRAZENECA AB, a corporation organized under the laws of Sweden, on
behalf of itself and its relevant Affiliates ("Seller"), and AAIPHARMA LLC, a
Delaware limited liability company ("Buyer"), a wholly-owned subsidiary of
aaiPharma Inc. and f/k/a NeoSan Pharmaceuticals Inc.

WHEREAS, Buyer and Seller are parties to that certain Asset Purchase Agreement,
dated as of July 25, 2001, (the "APA") relating to the sale by Seller and
purchase by Buyer of the Purchased Assets (as defined in the APA); and

WHEREAS, the parties now wish to amend certain terms and conditions of the APA
as set forth herein.

NOW, THEREFORE, in consideration of the foregoing and of the mutual covenants
and agreements contained herein, the receipt and sufficiency of which is hereby
acknowledged by the parties hereto, and intending to be legally bound hereby,
the parties hereby agree as follows:

         1.       DEFINITIONS. All capitalized terms used and not defined herein
shall have the meanings ascribed thereto in the APA.

         2.       AMENDMENT OF SECTION 1.01.

         The following definitions are hereby added to Section 1.01:

         (eeee) "Approvable Letter" means a written communication to an
applicant from FDA stating that FDA will approve the applicant's NDA if specific
additional information or material is submitted or specific conditions are met
in accordance with 21 CFR 314.110.

         (ffff) "Approval of Application" means a written communication to an
applicant from FDA approving the applicant's NDA in accordance with 21 CFR
3114.105.

         (gggg) "CFR" means the United States Code of Federal Regulations.

         (hhhh) "NDA" means a New Drug Application submitted in accordance with
the federal Food, Drug and Cosmetic Act, as amended.

         (iiii) "Payment Date" means August 17, 2004.

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         (jjjj) "Postapproval Study" means a study requested or required by FDA
as a condition to maintaining NDA approval.

         (kkkk) "Reformulation NDA" means each of (i) NDA 21-643 filed by Buyer
with FDA (relating to the pharmacy bulk package of Reformulated MVI-12 with ten
(10) doses per vial in a two-vial application), as the same may be amended or
supplemented, and (ii) NDA 21-625 filed by Buyer with FDA (relating to other
packaging configurations of Reformulated MVI-12), as the same may be amended or
supplemented.

         (llll) "Reformulated MVI-12" means MVI-12 Product that includes
increased dosages of vitamins B1, B6, C, and folic acid and the addition of
vitamin K in accordance with the Federal Register Notice published by the FDA on
April 20, 2000 [Docket No. 79N-0113]

3.       AMENDMENT OF SECTION 4.01.

         (a)      Subsection 4.01(a) is hereby amended by deleting the term
"Second Contingent Installment" from the parenthetical phrase contained in the
last clause thereof.

         (b)      Subsection 4.01(a)(iv) is hereby deleted in its entirety and
replaced with the word "Reserved."

         (c)      Subsection 4.01 (a)(v) is hereby deleted in its entirety and
replaced with the following:

                  "subject to Section 4.01A below, on the Payment Date, an
                  additional $43.5 million ("Remaining Purchase Price") in
                  immediately available funds by wire transfer into an account
                  designated by Seller two business days before such amount is
                  due;"

         (d)      The last paragraph of Section 4.01 is hereby deleted in its
entirety and replaced with the following new Section 4.01A:

                  "4.01A   Reduction of Remaining Purchase Price.

                           (a)      The Remaining Purchase Price shall be paid
                  to Seller in accordance with Section 4.01(a)(v) above if, with
                  respect to each Reformulation NDA, either (i) FDA delivers an
                  Approval of Application of such Reformulation NDA (which may
                  contain a request by FDA that one or more Postapproval Studies
                  be conducted with respect to Reformulated MVI-12 and which
                  Approval of Application shall cover each packaging
                  configuration submitted for approval in such Reformulation
                  NDA) and each packaging configuration of Reformulated MVI-12
                  approved in such Approval of Application has a minimum shelf
                  life of twelve months ("FDA Approval") or (ii) FDA delivers an
                  Approvable Letter with respect to such Reformulation NDA in
                  which FDA states that the only additional information

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                  or material required for approval of such Reformulation NDA by
                  FDA and/or the only conditions that are required to be
                  satisfied in order for FDA to approve such Reformulation NDA
                  (in either case, before approving the packaging configurations
                  covered thereby with minimum shelf lives of twelve months)
                  relate to the name of Reformulated MVI-12 ("FDA Approvable
                  Status"); provided that (x) if FDA Approval or FDA Approvable
                  Status of either Reformulation NDA is not obtained by December
                  31, 2002 (the "Penalty Date"), then the Remaining Purchase
                  Price shall be reduced by $1 million for each full month
                  thereafter until the month in which FDA Approval or FDA
                  Approvable Status of either Reformulation NDA is obtained
                  ("Monthly Penalty") and (y) if FDA Approval or FDA Approvable
                  Status of each Reformulation NDA is not obtained on or before
                  the Outside Date (as defined herein), then the Remaining
                  Purchase Price will equal zero. For purposes of this
                  Agreement, "Outside Date" means May 31, 2004, or such later
                  date as may be required in accordance with the following
                  paragraphs in this Section.

                           (b)      Buyer shall be solely responsible for
                  conducting any and all Postapproval Studies required by the
                  FDA with respect to Reformulated MVI. In no event will the
                  Remaining Purchase Price due to Seller or the Payment Date be
                  affected by FDA's requirement of Postapproval Studies.

                           (c)      If, in any Approvable Letter delivered by
                  FDA with respect to either Reformulation NDA, FDA states that
                  information or material is required for approval of such
                  Reformulation NDA by FDA and/or there are conditions that are
                  required to be satisfied in order for FDA to approve such
                  Reformulation NDA in addition to those relating to the name of
                  Reformulated MVI-12, Buyer shall provide Seller (i) with all
                  material information that is already in Buyer's possession at
                  the time of receipt of such Approvable Letter and is readily
                  available to be provided to Seller (the "Existing Data"), and
                  (ii) with reasonable reanalyses of such Existing Data, in each
                  case in (i) and (ii) above as reasonably requested by Seller
                  in connection with responding to such Approvable Letter, as
                  promptly as commercially practicable (and within five (5)
                  business days where commercially practicable) after such
                  request by Seller, or as mutually agreed to by the parties.
                  Notwithstanding the foregoing sentence, Buyer will respond
                  within five (5) business days to all Manufacturer requests
                  concerning the name of Reformulated MVI-12. If Buyer fails to
                  provide all such information of a material nature within the
                  timeframe specified in the preceding sentences, (a) the
                  Outside Date shall be extended by the number of days from the
                  end of the timeframe specified in the preceding sentences
                  through and including the day on which Buyer provides such
                  information (a "Delay Period") and (b) the accrual of the
                  Monthly Penalty shall be suspended for the Delay Period by
                  adding such Delay Period onto the end of the calendar month in
                  which such failure occurs before the Monthly Penalty would
                  again apply, with corresponding adjustments of the date

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                  that the Monthly Penalty would apply in subsequent months
                  where the circumstances therefor then apply. (By way of
                  example and not by way of limitation, if a six-day Delay
                  Period occurred in October 2003, the Monthly Penalty
                  previously applicable for October would thereafter apply six
                  days into November and six days into each subsequent month,
                  assuming the circumstances for the Monthly Penalty were then
                  applicable in such month.) In the event that such extension
                  would otherwise cause the Outside Date to fall on a day other
                  than a Business Day, the Outside Date shall be the next
                  succeeding Business Day. Such information that may be
                  requested from Seller hereunder, and readily available to be
                  provided to Seller, includes Existing Data pertaining to
                  analytical data, methods qualification data, analytical
                  methods validation information, specification setting, and
                  label issues, and reasonable reanalyses of Existing Data
                  related to the foregoing examples.

         4.       AMENDMENT OF APA SECTION 8.19.

         (a)      Section 8.19 is hereby amended by replacing the term
"Reformulation SNDA" in each place it appears with the term "Reformulation
NDAs."

         (b)      The language in the first sentence of Subsection 8.19(b)
reading "Upon the earlier of FDA's approval of the Reformulation SNDA or
Seller's notice to Buyer that it is abandoning its efforts to obtain such
approval," is hereby changed to read "Upon the earliest to occur of FDA Approval
or FDA Approvable Status of the two Reformulation NDAs, Seller's notice to Buyer
that it is abandoning its efforts to obtain such approval, or August 17, 2004."

         (c)      Subsection 8.19(d) is hereby amended by adding the following
new clause at the end thereof:

                  ", including all regulatory filing fees related to the filing
                  of the two Reformulation NDAs."

         5.       AMENDMENT OF SECTION 13.02.

                  The following provision is hereby added after the last
sentence of Section 13.02.

                  "Buyer shall provide to Seller a copy of all Governmental or
                  Regulatory Authority correspondence regarding either
                  Reformulation NDA received by Buyer, that does not clearly
                  indicate that Seller has also received a copy of such
                  correspondence, or a copy of all relevant portions of such
                  correspondence dealing with either Reformulation NDA, within
                  three (3) business days of receipt by Buyer. If Buyer fails to
                  provide any such correspondence within the timeframe specified
                  in the preceding sentence and Seller has not otherwise
                  received a copy of such correspondence, the Outside

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                  Date shall be extended by the relevant Delay Period (i.e., the
                  number of days from the end of the timeframe specified in the
                  preceding sentence through and including the day on which
                  Buyer provides such correspondence or relevant portions
                  thereof to Seller) and the accrual of the Monthly Penalty
                  shall be suspended for the Delay Period by adding such Delay
                  Period onto the end of the calendar month in which such
                  failure occurs before the Monthly Penalty would again apply,
                  with corresponding adjustments of the date that the Monthly
                  Penalty would apply with respect to subsequent months where
                  the circumstances therefor then apply. In the event that such
                  extension would otherwise cause the Outside Date to fall on a
                  day other than a Business Day, the Outside Date shall be the
                  next succeeding Business Day."

         6.       ASSIGNMENT. APA Section 13.07 is hereby deleted in its
entirety and replaced with the following:

                  "This Agreement may not be assigned by either party, in whole
                  or in part, without the prior written consent of the other
                  party, which consent shall not be unreasonably withheld.
                  Notwithstanding the foregoing, either party may assign this
                  entire Agreement and its rights and obligations hereunder to
                  any of its Affiliates with a guarantee of performance by the
                  assigning party. Any assignment in violation of this Section
                  shall be void. All validly assigned rights and obligations of
                  the parties shall be binding upon and inure to the benefit of
                  and be enforceable against the permitted assigns of such
                  party. If either party seeks and obtains the other party's
                  consent to assign its rights or obligations to a third party,
                  the assignee shall assume all rights and obligations of its
                  assignor under this Agreement."

         7.       NO OTHER AMENDMENTS. Except as expressly amended hereby, all
other terms and conditions of the APA shall remain in full force and effect.

         8.       HEADINGS. The headings used in this Amendment have been
inserted for convenience of reference only and do not define or limit the
provisions hereof.

         9.       GOVERNING LAW. THIS AMENDMENT SHALL BE GOVERNED BY AND
CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF DELAWARE APPLICABLE TO
CONTRACTS EXECUTED AND PERFORMED IN SUCH STATE, WITHOUT GIVING EFFECT TO
CONFLICTS OF LAWS PRINCIPLES.

         10.      COUNTERPARTS. This Amendment may be executed in any number of
counterparts and by facsimile, each of which will be deemed an original, but all
of which together will constitute one and the same instrument

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IN WITNESS WHEREOF, the parties have caused their respective duly authorized
officers to execute this Amendment which shall be effective as of the day and
year first above written.



aaiPHARMA LLC                          ASTRAZENECA AB



By: /S/ DAVID M. HURLEY                By: /S/ GLENN M. ENGELMANN
   ---------------------------            --------------------------------------
Name: David M. Hurley                  Name: Glenn M. Engelmann
Title: President                       Title: Attorney-in-fact
Date: July 22, 2003                    Date: July 25, 2003

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                      AMENDMENT TO AAIPHARMA INC. GUARANTY

         WHEREAS, pursuant to a Guaranty attached to the Asset Purchase
Agreement (the "APA"), dated as of July 25, 2001, by and between AstraZeneca AB,
on behalf of itself and its relevant Affiliates ("Seller"), andaaiPharma LLC,
f/k/a NeoSan Pharmaceuticals Inc. ("Buyer"), aaiPHARMA Inc. has guaranteed the
performance by Buyer of its obligations under the APA; and

         WHEREAS, Buyer and Seller have amended the APA on the foregoing terms
and conditions.

         NOW, THEREFORE, in consideration of Seller's entering into, and
continued performance under, the APA, the Guaranty is hereby amended to add the
phrase, "as amended from time to time," immediately after the word "Agreement"
in the fourth line thereof.

         IN WITNESS WHEREOF, aaiPHARMA Inc. has caused its duly authorized
officer to execute this amendment which shall be effective as of July 22, 2003.



                                       aaiPHARMA Inc.



                                       By: /S/ PHILIP S. TABBINER
                                          --------------------------------------
                                       Name: Philip S. Tabbiner
                                       Title: Chief Executive Officer

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