KEFLEX PRODUCTS TRANSITION AGREEMENT
EXHIBIT 10.8
This KEFLEX PRODUCTS TRANSITION AGREEMENT (this “Agreement”) is made as of November 7,
2007 between KEF PHARMACEUTICALS, INC., a Delaware corporation (“Kef”) and XXXXXXXXXXX
PHARMACEUTICALS, INC., a Delaware corporation (“XxxxxxXxxxx”).
Background Statement
Kef and XxxxxxXxxxx are parties to an Asset Purchase Agreement, dated as of the date of this
Agreement (the “Purchase Agreement”), and the Related Agreements (as defined in the
Purchase Agreement), pursuant to which Kef will acquire from XxxxxxXxxxx assets relating to certain
Cephalexin antibiotic products marketed under the name KEFLEX. Pursuant to a separate Consignment
Agreement, dated as of the date of this Agreement (the “Consignment Agreement”),
XxxxxxXxxxx will hold on consignment Kef’s entire inventory of finished Keflex Products and sell
such Keflex Products in the ordinary course of XxxxxxXxxxx’x business. Some of the Keflex Products
to be held and sold by XxxxxxXxxxx pursuant to the Consignment Agreement will be manufactured for
XxxxxxXxxxx pursuant to a Manufacturing Agreement between XxxxxxXxxxx and Ceph International Corp.
(“Ceph”), amended September 5, 2005. Upon the termination of the Consignment Agreement, it will be
necessary for Kef to thereafter manufacture, distribute and sell the Keflex Products. This
Agreement sets forth the agreement of the parties regarding the transition of the manufacture,
distribution and sale of Keflex Products from XxxxxxXxxxx to Kef in the event of such termination.
Statement of Agreement
1. Definitions.
(a) Terms defined in the Purchase Agreement shall have the same meaning when used herein.
(b) The following terms shall have the meanings set forth below.
“Chargeback Date” means the last day of the first full month following the Transition
Date.
“Chargebacks” has the meaning set forth in Section 4.
“Consignment Agreement” has the meaning set forth in the Background Statement.
“Contingent Manufacturing Assignment Agreement” has the meaning set forth in Section
2(b).
“Keflex Products” means all dosage forms, formulations, strengths and package sizes
and types of any cephalexin antibiotic products that may be marketed now or in the future under the
NDA.
“Lex Asset Purchase Agreement” means that certain Asset Purchase Agreement, dated as
of the date hereof, between XxxxxxXxxxx and Lex Pharmaceuticals, Inc.
“NDA” means the approved new drug applications number 50-405 and 50-406, including all
supplements and amendments thereto.
“Party” means either XxxxxxXxxxx or Kef and “Parties” means both XxxxxxXxxxx
and Kef.
“Purchase Agreement” has the meaning set forth in the Background Statement.
“Transition Date” means the date on which the Consignment Agreement terminates.
2. Transfer of Responsibilities, Product and Books and Records. Upon the Transition
Date, XxxxxxXxxxx shall take the actions described in this Section 2.
(a) Consigned Merchandise. As of the Transition Date, XxxxxxXxxxx shall cease all
sales and shipments of Consigned Merchandise (as defined in the Consignment Agreement) and shall
deliver to Kef any outstanding orders for Keflex Products. Within five (5) days after the
Transition Date, XxxxxxXxxxx shall dispatch all Keflex Products for delivery to Kef at such
destination(s), and in accordance with such freight instructions, as Kef may have specified in
writing not less than five (5) days prior to the date of dispatch. Kef shall pay the freight costs
for shipping the Keflex Products to Kef.
(b) Assignment of Manufacturing Agreement. As of and after the Transition Date,
XxxxxxXxxxx shall take such actions and execute and deliver such documents as may be necessary to
carry out the terms and provisions of the Contingent Manufacturing Assignment Agreement, which is
attached as Exhibit F to the Lex Asset Purchase Agreement.
(c) Keflex Records. As of and after the Transition Date, XxxxxxXxxxx shall transfer (i) all
records of XxxxxxXxxxx relating to the Keflex Products including all historical sales records and
(ii) a complete and accurate copy of all Technical Data Embodiments within the scope of Section
2.1(a)(i) and, if the Patent License (as defined in the Purchase Agreement) has been executed by
XxxxxxXxxxx and Kef, the Technical Data Embodiments in Section 2.1(a)(ii) of the Lex Asset Purchase
Agreement. Kef shall pay the freight costs for shipping such records to Kef. XxxxxxXxxxx may
retain copies of those records that XxxxxxXxxxx is required to maintain by any Legal Requirement or
requires for the auditing of its financial statements.
(d) Product Labeling. As of and after the Transition Date, XxxxxxXxxxx shall xxxxx to Kef the
right to receive, market and sell Keflex Products that have been manufactured on or before the
Transition Date and bearing a label with XxxxxxXxxxx’x name, provided such Keflex Products are sold
in unaltered form in compliance with all Regulatory Obligations before their respective expiration
dates.
3. Products Returns. XxxxxxXxxxx shall be responsible for making any refunds relating
to returns of Keflex Products sold by XxxxxxXxxxx prior to the Transition Date and shall deliver to
Kef any Keflex Products physically returned to XxxxxxXxxxx. Kef shall be responsible for all
returns of Keflex Products sold by Kef after the Transition Date. With respect to any
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batch of Keflex Products sold both before and after the Transition Date, the financial responsibility
for returns shall be allocated between the Parties in proportion to their respective sales of each
SKU sold both before and after the Transition Date.
4. Chargebacks and Rebates. XxxxxxXxxxx shall be responsible for and shall pay all
chargebacks and rebates related to sales of Keflex Products under arrangements of XxxxxxXxxxx with
Governmental Authorities (“Chargebacks”) that are first submitted on or before the
Chargeback Date, and Kef shall be responsible for and pay all Chargebacks that are first submitted
after the Chargeback Date.
5. Indemnification; Insurance.
(a) Indemnification by XxxxxxXxxxx. XxxxxxXxxxx shall defend, indemnify and hold
harmless Kef from and against all liabilities, losses, obligations, claims, judgments, awards,
relief, settlements, costs and expenses (including costs of any product recall and reasonable
attorneys’ fees, experts’ fees, investigation costs and other expenses of litigation) which Kef,
its members, managers, directors, officers, employees and representatives may suffer or incur
arising out of XxxxxxXxxxx’x use, manufacture, marketing, advertising or sale of Keflex Products.
(b) Indemnification by Kef. Kef shall defend, indemnify and hold harmless XxxxxxXxxxx
from and against all liabilities, losses, obligations, claims, judgments, awards, relief,
settlements, costs and expenses (including costs of any product recall and reasonable attorneys’
fees, experts’ fees, investigation costs and other expenses of litigation) which XxxxxxXxxxx, its
directors, officers, employees and representatives may suffer or incur arising out of Kef’s use,
manufacture, marketing, advertising or sale of Keflex Products after the Transition Date.
(c) Insurance. For a period of five (5) years following the Transition Date,
XxxxxxXxxxx shall maintain general liability insurance under customary pharmaceutical industry
forms and endorsements, providing product liability and contractual liability coverage, with per
occurrence limits of not less than $10,000,000. XxxxxxXxxxx shall cause the insurer(s) issuing
such policy(ies) to provide Kef with certificates of insurance evidencing the existence of such
insurance, which certificates shall provide that the insurer will notify Kef not less than thirty
(30) days prior to any expiration, non-renewal, cancellation, reduction in limits or exhaustion of
limits of such insurance.
6. General Provisions.
(a) Amendment; Waiver. This Agreement, including any schedules and exhibits hereto,
may be amended, modified or supplemented only by an agreement in writing signed by the Parties. No
course of dealing between the Parties or failure by a Party to exercise any right or remedy
hereunder shall constitute an amendment to this Agreement or a waiver of any other right or remedy
or the later exercise of any right or remedy.
(b) Force Majeure. No Party shall be responsible to any other Party for any failure
or delay in performing any of its obligations under this Agreement or for other nonperformance
hereof if such delay or nonperformance is caused by fire, flood, accident, act of God or of the
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government or any country or of any state or local government, or of the public enemy of
either, or by cause unavoidable or beyond the control of such Party. In such event, the Party
affected shall use commercially reasonable efforts to resume performance of its obligations.
(c) Headings. The section headings of this Agreement are for convenience of reference
only and shall not affect the meaning or interpretation of this Agreement in any way. This
Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective
successors and assigns.
(d) Notices. All notices, consents, waivers and other communications hereunder shall
be in writing and shall be (i) delivered by hand, (ii) sent by facsimile transmission or (iii) sent
by a nationally recognized overnight delivery service, charges prepaid, to the address set forth
below (or such other address for a Party as shall be specified by like notice):
If to XxxxxxXxxxx, to:
|
XxxxxxXxxxx Pharmaceuticals, Inc. | |
| 00000 Xxxxxx Xxxxxxx Xxxxxxx | ||
| Xxxxxxxxxx, Xxxxxxxx 00000 | ||
| Attention: Xxxxxx X. Xxxxxx, Ph.D. | ||
| Facsimile: (000) 000-0000 | ||
Copy to:
|
Xxxxx & XxXxxxx LLP | |
| 0000 Xxxxxx xx xxx Xxxxxxxx | ||
| Xxx Xxxx, Xxx Xxxx 00000 | ||
| Attention: Xxxxxxxxx X. Xxxxxx, Esq. | ||
| Facsimile: (000) 000-0000 | ||
If to Kef, to:
|
Kef Pharmaceuticals, Inc. | |
| 000 0xx Xxxxxx, 00xx Xxxxx | ||
| Xxx Xxxx, Xxx Xxxx 00000 | ||
| Attention: Xxxxx X. Xxxxx | ||
| Facsimile: | ||
Copy to:
|
Xxxxxxxx, Xxxxxxxx & Xxxxxx, P.A. | |
| 000 Xxxxx Xxxxx Xxxxxx, Xxxxx 0000 | ||
| Xxxxxxxxx, Xxxxx Xxxxxxxx 00000 | ||
| Attention: Xxxxx X. Xxxxx | ||
| Facsimile: (000) 000-0000 |
Each such notice or other communication shall be deemed to have been duly given and to be
effective if (A) delivered by hand, immediately upon delivery if delivered on a Business Day during
normal business hours and, if otherwise, on the next Business Day, (B) sent by facsimile
transmission, immediately upon confirmation that such transmission has been successfully
transmitted on a Business Day before or during normal business hours and, if otherwise, on the
Business Day following such confirmation, or (C) sent by a nationally recognized overnight delivery
service, on the day of delivery by such service or, if not a Business Day, on the first Business
Day after delivery. Notices and other communications sent via facsimile must be
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followed by notice delivered by hand or by overnight delivery service as set forth herein
within five (5) Business Days.
(e) Assignment; No Third Party Rights. This Agreement and all of the provisions
hereof shall be binding upon and inure to the benefit of the Parties and their respective
successors and permitted assigns. This Agreement may not be assigned by XxxxxxXxxxx without the
prior written consent of Kef, which consent Kef may withhold or grant in its sole discretion.
Notwithstanding the preceding sentence, after the purchase of all of the capital stock of Kef by
XxxxxxXxxxx, XxxxxxXxxxx may assign this Agreement along with its entire business. Kef may assign
this Agreement to any Person who receives an assignment of Kef’s interest in the Purchase Agreement
or the Related Agreements. This Agreement and its provisions are for the sole benefit of the
Parties and their successors and permitted assigns and shall not give any other Person any legal or
equitable right, remedy or claim.
(f) Governing Law; Venue. The execution, interpretation and performance of this
Agreement, and any disputes with respect to the transactions contemplated by this Agreement,
including any fraud claims, shall be governed by the internal laws and judicial decisions of the
State of New York, without regard to principles of conflicts of laws.
(g) Severability. If any provision contained in this Agreement shall for any reason
be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provision of this Agreement, and this Agreement shall
be construed as if such invalid, illegal or unenforceable provision had never been contained
herein, unless the invalidity of any such provision substantially deprives either Party of the
practical benefits intended to be conferred by this Agreement. Notwithstanding the foregoing, any
provision of this Agreement held invalid, illegal or unenforceable only in part or degree shall
remain in full force and effect to the extent not held invalid or unenforceable, and the
determination that any provision of this Agreement is invalid, illegal or unenforceable as applied
to particular circumstances shall not affect the application of such provision to circumstances
other than those as to which it is held invalid, illegal or unenforceable.
(h) Construction. Each Party acknowledges that it and its attorneys have been given
an equal opportunity to negotiate the terms and conditions of this Agreement and that any rule of
construction to the effect that ambiguities are to be resolved against the drafting Party or any
similar rule operating against the drafter of an agreement shall not be applicable to the
construction or interpretation of this Agreement.
(i) Related Agreement. This Agreement including the Purchase Agreement and Related
Agreements, appendices, schedules and exhibits thereto, are intended to be construed as parts of a
group of related transactions and shall be construed accordingly.
(j) Counterparts. This Agreement may be executed in multiple counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same
instrument. This Agreement may be executed on signature pages exchanged by facsimile, in which
event each Party shall promptly deliver to the others such number of original executed copies as
the other Party may reasonably request.
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(k) No Joint Venture. The relationship between the Parties hereto is that of
independent contractors. Such Parties are not joint venturers, partners, principal and agent,
master and servant, employer or employee, and have no relationship other than as independent
contracting parties. Neither Party shall have the power to bind or to obligate the other in any
manner.
[Signatures are on the following page.]
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IN WITNESS WHEREOF, the parties hereto have cause this Keflex Products Transition Agreement to
be executed by their duly authorized representatives as of the date first above written.
| KEF PHARMACEUTICALS, INC. | ||||||
| By: | /s/ Xxxxx X. Xxxxxxxx | |||||
| Name: Xxxxx X. Xxxxxxxx |
||||||
| Title: President | ||||||
| XXXXXXXXXXX PHARMACEUTICALS, INC. | ||||||
| By: | /s/ Xxxxxx X. Xxxxxx | |||||
| Name: Xxxxxx X. Xxxxxx, Ph.D. | ||||||
| Title: President and Chief Executive Officer | ||||||
