EXHIBIT 10.5
PATENT LICENSE AGREEMENT
This PATENT LICENSE AGREEMENT
(this “ Agreement ”) is made as of
, 200___ between MIDDLEBROOK PHARMACEUTICALS, INC. , a
Delaware corporation (“ MiddleBrook ”) and
KEF PHARMACEUTICALS, INC. , a Delaware corporation (“
Kef ”). MiddleBrook and Kef are each referred to
individually as a “ Party ,” and collectively as
the “ Parties .”
Background Statement
MiddleBrook and Kef are Parties to an
Asset Purchase Agreement, dated as of November ___, 2007 (the
“ Purchase Agreement ”), and are entering into
this Agreement pursuant to Section 3.4(e)(ii) of the Purchase
Agreement for the purpose of granting to Kef an exclusive license
under the Licensed Patents (as defined in the Purchase Agreement)
set forth on Schedule A (the “ Licensed
Patents ”).
Statement of Agreement
1.
Definitions .
1.1 Terms Defined in Purchase
Agreement . Terms defined in the Purchase Agreement and not
otherwise defined by this Agreement shall have the meaning given to
such terms in the Purchase Agreement.
1.2 “ Adverse Drug
Experience ” means the definition in the current 21
C.F.R. Section 314.80, as in effect from time to time.
1.3 “ Agreement ”
has the meaning set forth in the introductory paragraph.
1.4 “ Kef ” has
the meaning set forth in the introductory paragraph.
1.5 “ Keflex Products
” has the meaning given it in the Sublicense.
1.6 “ License ”
has the meaning set forth in Section 2 .
1.7 “ Licensed Patents
” has the meaning set forth in the Background
Statement.
1.8 “ Licensed Products
” means all products that may now or hereafter be sold under
the Sublicense.
1.9 “ MiddleBrook
” has the meaning set forth in the introductory
paragraph.
1.10 “ MiddleBrook’s
Knowledge ” has the meaning given the
“Seller’s Knowledge” in the Purchase
Agreement.
1.11 “ Party ”
means either MiddleBrook or Kef and “ Parties ”
shall mean both MiddleBrook and Kef.
1.12 “ Purchase
Agreement” has the meaning set forth in the Background
Statement.
1.13 “ Regulatory
Obligations ” has the meaning set forth in
Section 5.1 .
1.14 “ Related
Agreements ” has the meaning set forth in the Purchase
Agreement.
1.15 “ Sublicense
” means the Patent Sublicense Agreement, dated as of the date
hereof, between MiddleBrook and Kef pursuant to which Kef shall
grant a sublicense to MiddleBrook under the Licensed Patents.
1.16 “ Territory ”
means the United States of America and Puerto Rico.
2. Grant of
License . MiddleBrook hereby grants to Kef, upon and
subject to the terms and conditions of this Agreement, a perpetual,
irrevocable, royalty-free, exclusive (even as to MiddleBrook)
license under the Licensed Patents to develop, make, have made,
import, offer for sale and sell Keflex Products in the Territory
(the “ License ”).
3. Ownership of
Licensed Patents . Kef acknowledges that, as between Kef
and MiddleBrook, MiddleBrook is the sole and exclusive owner of the
Licensed Patents, and Kef shall do nothing inconsistent with such
ownership. Kef shall not challenge MiddleBrook’s ownership
and rights in or to any of the Licensed Patents or assist others in
challenging MiddleBrook’s ownership thereof. Kef agrees that
nothing in this Agreement shall give Kef any right, title or
interest in the Licensed Patents other than the License granted
herein. Upon MiddleBrook’s request, Kef shall provide such
information and assistance, and execute and deliver such documents,
as MiddleBrook may reasonably request for purposes of registering,
maintaining or enforcing any of the Licensed Patents.
4.
Representations and Warranties . MiddleBrook
represents and warrants to Kef that: (i) the Licensed Patents
constitute all Patents related to or used by MiddleBrook in
connection with the manufacture, sale or development of Keflex
Products; (ii) each of the Licensed Patents, if issued, is in
full force and effect; (iii) all fees necessary to maintain
the issued Licensed Patents have been paid in full when due, and
there are currently no maintenance fees due for any of the issued
Licensed Patents; (iv) there has been no action by the United
States Patent and Trademark Office to reexamine, terminate or
cancel any Licensed Patent or to decline to issue any Licensed
Patent that has not been issued; (v) MiddleBrook has not
granted any license under any of the Licensed Patents to develop,
make, have made, import, offer for sale or sell Keflex Products
other than the license to Kef under this Agreement and;
(vi) to MiddleBrook’s Knowledge, no Person (A) has
claimed that any Licensed Patent is invalid or unenforceable or
(B) is currently infringing any Licensed Patent.
5. Regulatory
Obligations .
5.1 Performance by MiddleBrook
. MiddleBrook shall take all reasonable and appropriate actions, at
MiddleBrook’s sole cost and expense, to maintain the Licensed
Patents and shall oversee, monitor, coordinate and perform all
regulatory actions, communications and filings with and
submissions, including filings and submissions of supplements and
amendments thereto, to each applicable Regulatory Authority or
Governmental Authority with respect to each Patent (the “
Regulatory Obligations ”). Notwithstanding the
foregoing, nothing herein shall operate to prevent Kef from taking
such actions as Kef, in its sole discretion, deems
appropriate
2
to
ensure that all Regulatory Obligations are properly and timely
performed, subject to prior notice to and consultation with
MiddleBrook.
5.2 Regulatory Meetings and
Correspondence . MiddleBrook shall be responsible for
interfacing, corresponding and meeting with the applicable
Regulatory Authorities with respect to each Patent. Kef shall
execute such notices, powers of attorney, acknowledgments, consents
and other instruments as MiddleBrook may reasonably request to
authorize MiddleBrook to act on Kef’s behalf for all actions
before and communications with Regulatory Authorities and other
Governmental Authorities, including the United States Patent and
Trademark Office, as shall be necessary and appropriate to enable
MiddleBrook to perform the Regulatory Obligations.
5.3 Exchange of Information .
The Parties shall establish procedures to ensure that the Parties
exchange on a timely basis all necessary information to enable
MiddleBrook to comply with all Regulatory Obligations, including,
without limitation, filing updates, pharmacovigilance filings and
investigator notifications. To the extent either Party receives any
information regarding Adverse Drug Experiences related to the use
of any Keflex Products, such Party shall, (i) within five
(5) days of its receipt of such information, provide the other
Party with such information, (ii) promptly provide all
follow-up information that may reasonably be requested and
(iii) otherwise act in accordance with such Adverse Event
Reporting Procedures to be agreed upon in writing by the Parties
from time to time. Without limiting the foregoing requirement,
MiddleBrook shall provide Kef with copies of all communications
between MiddleBrook and any Governmental Authorities relating to
any of the Licensed Patents, Approved Registrations, IND and Keflex
Products, in every case within five (5) Business Days of the
sending or receipt of such communication by MiddleBrook.
5.4 Costs and Expenses .
MiddleBrook shall bear all costs and expenses of performing the
Regulatory Obligations.
6. Infringement
of Licensed Patents .
6.1 Conduct of Actions . If
either Party shall receive notice of any infringement or threatened
infringement of any of the Licensed Patents, such Party shall
immediately notify the other Party of such infringement or
threatened infringement, providing all information relating thereto
possessed by the notifying Party. Except as provided below,
MiddleBrook may initiate and control any legal action relating to
infringement of any of the Licensed Patents; provided, however,
that (i) MiddleBrook shall keep Kef fully apprised of all
activity in such action, (ii) Kef shall have the right to
participate in such action at its own expense,
(iii) MiddleBrook shall not take any position in such action
inconsistent with Kef’s exclusive license under the Licensed
Patents and (iv) no settlement of any such action shall be
made without the consent of Kef, which shall not be unreasonably
withheld or delayed. Upon notice of infringement, if MiddleBrook
fails within a reasonable time thereafter to initiate legal action
relating to any such infringement of any of the Licensed Patents,
or if the Sublicense shall have terminated, Kef may initiate and
control any legal action relating to infringement of the Licensed
Patents relating to the Keflex Products. The Parties hereby agree
that either Party may include the other as a party plaintiff in any
such action and that each Party shall cooperate, a
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