PATENT LICENSE AGREEMENT
EXHIBIT 10.5
This
PATENT LICENSE AGREEMENT (this “Agreement”)
is made as of
, 200___
between XXXXXXXXXXX PHARMACEUTICALS, INC., a Delaware corporation (“XxxxxxXxxxx”) and KEF
PHARMACEUTICALS, INC., a Delaware corporation (“Kef”). XxxxxxXxxxx and Kef are each
referred to individually as a “Party,” and collectively as the “Parties.”
Background Statement
XxxxxxXxxxx 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 “XxxxxxXxxxx” has the meaning set forth in the introductory paragraph.
1.10 “XxxxxxXxxxx’x Knowledge” has the meaning given the “Seller’s Knowledge” in the
Purchase Agreement.
1.11 “Party” means either XxxxxxXxxxx or Kef and “Parties” shall mean both
XxxxxxXxxxx 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 XxxxxxXxxxx and Kef pursuant to which Kef shall grant a sublicense to XxxxxxXxxxx under the
Licensed Patents.
1.16 “Territory” means the United States of America and Puerto Rico.
2. Grant of License. XxxxxxXxxxx hereby grants to Kef, upon and subject to the terms
and conditions of this Agreement, a perpetual, irrevocable, royalty-free, exclusive (even as to
XxxxxxXxxxx) 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
XxxxxxXxxxx, XxxxxxXxxxx is the sole and exclusive owner of the Licensed Patents, and Kef shall do
nothing inconsistent with such ownership. Kef shall not challenge XxxxxxXxxxx’x ownership and
rights in or to any of the Licensed Patents or assist others in challenging XxxxxxXxxxx’x 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 XxxxxxXxxxx’x request, Kef shall
provide such information and assistance, and execute and deliver such documents, as XxxxxxXxxxx may
reasonably request for purposes of registering, maintaining or enforcing any of the Licensed
Patents.
4. Representations and Warranties. XxxxxxXxxxx represents and warrants to Kef that:
(i) the Licensed Patents constitute all Patents related to or used by XxxxxxXxxxx 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) XxxxxxXxxxx 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 XxxxxxXxxxx’x 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 XxxxxxXxxxx. XxxxxxXxxxx shall take all reasonable and appropriate
actions, at XxxxxxXxxxx’x 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
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to ensure that all Regulatory Obligations are properly and timely performed, subject to prior
notice to and consultation with XxxxxxXxxxx.
5.2 Regulatory Meetings and Correspondence. XxxxxxXxxxx 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 XxxxxxXxxxx may reasonably request to authorize XxxxxxXxxxx 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 XxxxxxXxxxx 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 XxxxxxXxxxx 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, XxxxxxXxxxx
shall provide Kef with copies of all communications between XxxxxxXxxxx 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 XxxxxxXxxxx.
5.4 Costs and Expenses. XxxxxxXxxxx 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, XxxxxxXxxxx may initiate and
control any legal action relating to infringement of any of the Licensed Patents; provided,
however, that (i) XxxxxxXxxxx 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) XxxxxxXxxxx 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 XxxxxxXxxxx 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, at the expense of the Party controlling the
relevant legal action, in the prosecution of such action as reasonably requested by the Party
controlling such action. Any monetary recovery in connection with such action shall
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first be applied to reimburse XxxxxxXxxxx and Kef for out-of-pocket expenses (including
attorneys’ fees) incurred in prosecuting such action. Any remaining monetary recovery in such
action shall be equitably divided between the Parties on the basis of their respective damages
resulting from the claimed infringement. The Party controlling any legal action pursuant to this
Section 6.1 shall bear all expenses of such action, other than the fees of any counsel the other
Party may engage if it chooses to participate separately in such action.
6.2 Action Initiated Against Kef. In the event that a declaratory judgment action
alleging invalidity or infringement of any of the Licensed Patents shall be brought against Kef,
XxxxxxXxxxx, at its option, shall have the right, within thirty (30) days after commencement of
such action, to intervene and take over the sole defense of the action at its own expense.
6.3 Cooperation. In any infringement action, either Party may institute to enforce
the Licensed Patents pursuant to this Agreement, the other Party shall, at the expense of the Party
initiating such action, reasonably cooperate and, to the extent possible, have its applicable
employees testify when requested and make available relevant records, papers, information, samples,
specimens and the like.
7. Indemnification; Insurance.
7.1 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 shareholders, directors, officers, employees and representatives may suffer or incur arising
out of (i) the development, manufacture, marketing, advertising, sale or use by XxxxxxXxxxx or its
successors, directly or indirectly, of the Licensed Products (excluding any such activities
conducted by Kef or its successors, in connection with the Keflex Products, if the Sublicense
should terminate), (ii) the performance or failure of performance by XxxxxxXxxxx of the Regulatory
Obligations and (iii) the breach by XxxxxxXxxxx of this Agreement. XxxxxxXxxxx shall not be
obligated to so indemnify, defend and hold harmless Kef to the extent that any such claim, expense,
proceeding, demand or liability arises from the gross negligence or willful misconduct of Kef.
7.2 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
shareholders, directors, officers, employees and representatives may suffer of incur arising out of
(i) the development, manufacture, marketing, advertising, sale or use by Kef or its successors of
the Keflex Products (excluding any such activities conducted by XxxxxxXxxxx or its successors
pursuant to the Sublicense) or (ii) the breach by Kef of this Agreement. Kef shall not be
obligated to so indemnify, defend and hold harmless XxxxxxXxxxx to the extent that any claim,
expense, proceeding, demand or liability arises from the negligence or willful misconduct of
XxxxxxXxxxx.
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7.3 Procedure. A Party that intends to claim indemnification under this Section 7
(“Indemnitee”) shall promptly notify the other Party (the “Indemnitor”) of any
claim, damage, liability, cause of action or cost with respect to which the Indemnitee intends to
claim such indemnification. Indemnitor, after it determines that indemnification is required of
it, shall assume the defense thereof with counsel of its own choosing; provided, however, that an
Indemnitee shall have the right to retain its own counsel, with the expenses to be paid by
Indemnitor, if Indemnitor does not assume the defense. The agreement of indemnity contained in
this Section 7 shall not apply to amounts paid in settlement of any claim, damage, liability, cause
of action or cost if such settlement is effected without the consent of Indemnitor, which consent
shall not be unreasonably withheld. Indemnitor shall keep Indemnitee informed of, and consult with
Indemnitee in connection with, the progress of such litigation or settlement, and Indemnitor shall
not have the right, without Indemnitee’s written consent, to settle any such claim if such
settlement arises from or is part of any criminal action, suit or proceeding or contains a
stipulation to or admission or acknowledgement of any liability or wrongdoing (whether in contract,
tort or otherwise) on the part of Indemnitee. The failure to deliver notice to Indemnitor within a
reasonable time after the commencement of any such action, if prejudicial to the Indemnitor’s
ability to defend such action, shall relieve such Indemnitor of liability to the Indemnitee under
this Section 7 to the extent of such prejudice, but the omission to deliver notice to Indemnitor
will not relieve it of any liability that it may have to any Indemnitee otherwise than under this
Section 7. Indemnitee shall, and shall use commercially reasonable efforts to cause its employees
and agents to, cooperate reasonably with Indemnitor and its legal representatives in the
investigation and defense of any claim, damage, liability, cause of action or cost covered by this
indemnification.
7.4 Limitation of Liability. THE PARTIES AGREE THAT, NOTWITHSTANDING ANY OTHER
PROVISION HEREOF, NO PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE TO ANY OTHER PARTY OR ANY
OTHER PERSON OR ENTITY FOR DAMAGES IN THE FORM OF CONSEQUENTIAL, INCIDENTAL OR SPECIAL DAMAGES,
LOST PROFITS, LOST SAVINGS OR OTHERWISE, OR FOR EXEMPLARY DAMAGES, EVEN IF THE FIRST PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED, HOWEVER, THAT THE FOREGOING
LIMITATION DOES NOT APPLY TO ANY SUCH DAMAGES WHICH MAY BE PAYABLE TO A THIRD PARTY BY A PARTY
HERETO FOR WHICH SUCH PARTY IS INDEMNIFIED HEREUNDER.
8. General Provisions.
8.1 Amendment; Waiver. This Agreement, including the Schedules 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.
8.2 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
government or any country or of any state or local government, or of the public enemy of either,
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or by cause unavoidable or beyond the control of such Party. In such event, the Party
affected will use reasonable commercial efforts to resume performance of its obligations.
8.3 Headings. The headings of Articles and Sections 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.
8.4 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 certified mail or 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
(x) if delivered by hand, immediately upon delivery if delivered on a Business Day during normal
business hours and, if otherwise, on the next Business Day; (y) if 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 (z) if 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 followed by notice delivered
by hand or by overnight delivery service as set forth herein within five (5) Business Days.
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8.5 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
and 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.
8.6 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.
8.7 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.
8.8 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.
8.9 Entire Agreement. This Agreement, including the Purchase Agreement and Related
Agreements, Appendices, Schedules, Annexes and Exhibits, constitutes the entire agreement and
understanding of the Parties hereto in respect of the subject matter hereof. The Purchase
Agreement and Related Agreements, Appendices, Schedules, Annexes and Exhibits hereto are an
integral part of this Agreement and are incorporated by reference herein.
8.10 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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8.11 No Joint Venture. The relationship between the Parties is that of independent
contractors. The 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 obligate the other in any manner.
[Signatures are on the following page.]
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IN WITNESS WHEREOF, the Parties are entering into this Patent License Agreement as of the date
first above written.
| KEF PHARMACEUTICALS, INC. | ||||||
| By: | ||||||
| Name: | ||||||
| Title: | ||||||
| XXXXXXXXXXX PHARMACEUTICALS, INC. | ||||||
| By: | ||||||
| Name: | ||||||
| Title: | ||||||
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