Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment which has been filed separately with the SEC. License Agreement between Vanderbilt University and Cumberland Pharmaceuticals Inc.
EXHIBIT 10.10
*Certain portions of this exhibit have been omitted pursuant to a request for confidential
treatment which has been filed separately with the SEC.
treatment which has been filed separately with the SEC.
between
Vanderbilt University
and
May 1999
THIS AGREEMENT, by and between VANDERBILT UNIVERSITY, a not-for-profit corporation, organized and
existing under the laws of the state of Tennessee (“VANDERBILT”), and Cumberland Pharmaceuticals
Inc., a Tennessee corporation, having a principal place of business at Nashville, Tennessee (the
“LICENSEE”) is effective as of the 28TH day of May , 1999 (the
“EFFECTIVE DATE”).
RECITALS
WHEREAS, VANDERBILT represents that it holds title, by assignment, to the data, including patient
records, created by Xxxxxx X. Xxxxxxx, M.D., Professor of Medicine (“the Data”) relating to
intravenously administered ibuprofen for treatment of sepsis and that it has all rights to the Data
and VANDERBILT is willing to grant a license to the Data and any intellectual property rights
associated therewith; and
WHEREAS, LICENSEE desires to acquire, and VANDERBILT desires to grant to LICENSEE, an exclusive,
worldwide license to use the Data in connection with the development and production of the
“Product,” as hereinafter defined, for which LICENSEE intends to seek necessary approvals from
regulatory governmental agencies in order to market and sell such products upon the terms and
conditions hereinafter set forth;
NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, it is
agreed by the parties as follows:
1. DEFINITIONS
1.1 Product(s) shall mean a pharmaceutical product, consisting, in whole or part, of
intravenously administered ibuprofen manufactured by or for LICENSEE based on the Data and approved
by a regulatory agency for sale or other distribution in the country in which the agency has
regulatory authority.
1.2 Net Sales. The term “Net Sales” shall mean the receipts for Products sold by LICENSEE
or a sublicense during the term of this Agreement, computed quarter by quarter, less allowances
for:
(a) cash, trade, or quantity discounts and rebates,
(b) taxes, including sales taxes and duties,
(c) credits, returns and replacements, and
(d) shipping and insurance charges.
Products shall be deemed sold when paid for.
1
1.3 The Inventor. The term “Inventor” shall mean Xxxxxx X. Xxxxxxx, M.D., Professor of
Medicine.
1.4 Affiliate means, when used with reference to LICENSEE, any entity directly or
indirectly controlling, controlled by or under common control with LICENSEE. For purposes of this
Agreement, “control” means the direct or indirect ownership of over fifty percent (50%) of the
outstanding voting securities of an entity, or the right to receive over fifty percent (50%) of the
profits or earnings of an entity, or the right to control the policy decisions of an entity.
2. GRANT
2.0 Exclusive License. VANDERBILT hereby grants to LICENSEE and LICENSEE hereby accepts
from VANDERBILT, upon the terms and conditions herein specified, an exclusive, royalty bearing,
worldwide license, with the right to sublicense, to use Data for any purpose, including manufacture
and sale of the Product(s) as well as submission to regulatory governmental agencies for approval
to sell Product(s), except as otherwise expressly set forth herein. Upon execution of this
Agreement, VANDERBILT through Xxxxxx Xxxxxxx will promptly deliver to LICENSEE all information and
data relating to intravenously administered ibuprofen to which VANDERBILT holds title.
2.1 Federal Government Rights Reserved. Notwithstanding the exclusive license granted
herein, the Federal Government shall receive all the rights, if any, to the Data required by law or
regulation to be reserved to the government. All rights granted in this Agreement are expressly
granted subject to the rights of the Federal Government and such rights are specifically reserved
to the Government by this Agreement.
2.2 Reservation of Right. VANDERBILT reserves the right to make, use and further develop
the Data for its own non-commercial, educational and research purposes.
2.3 Upon receipt of regulatory approval to sell the Product, LICENSEE shall use reasonable efforts
to effect introduction of the Products into the commercial market as soon as practicable,
consistent with sound and reasonable business practices and judgment; thereafter, until the
expiration of this Agreement, LICENSEE shall use commercially reasonable efforts to keep Products
reasonably available to the public.
2.4 Subsidiaries and Distributors. License rights granted hereunder shall enable LICENSEE
to make, use, sell or otherwise distribute Product through any of its subsidiaries and to sell
Product through any of its normal channels including its subsidiaries, distributors, and agents.
2
3. TERMS AND TERMINATION
3.0 Term. Unless previously terminated as herein provided, this Agreement shall become
effective as stated above and shall continue until LICENSEE ceases distribution of Product in all
countries in which it has obtained regulatory approval for manufacture and distribution of such
product based on use of the Data.
3.1 Termination. This Agreement may be terminated by written notice to the other party:
(a) Other than as stated in Article 3.1(b), in the event that one party commits any
substantial breach of this Agreement, the non-breaching party at its option, may terminate this
Agreement by giving the breaching party written notice pursuant to Article 10.2 of its election to
terminate as of a stated date, not less than forty-five (45) days from the date of the notice.
Such notice shall state the nature of the defaults claimed by the non-breaching party. The
breaching party during said forty-five (45) day period, or such longer period as may be indicated
by the other, may correct any default stated in said notice and if such default is corrected, this
Agreement shall continue in full force and effect as if such notice had not been given. Failure by
LICENSEE to pay earned royalties to VANDERBILT in a timely manner shall be deemed a substantial
breach of the Agreement.
(b) In the event LICENSEE shall file a petition for voluntary bankruptcy, has a petition for
involuntary bankruptcy filed against it (which petition is not withdrawn within sixty (60) days of
such filing), is adjudicated to be bankrupt, or shall make an assignment for the benefit of
creditors, or shall apply for or consent to the appointment of a receiver or trustee of a
substantial part of its property, to the extent permitted by law, this Agreement shall
automatically terminate effective as of a date ten (10) days prior to LICENSEE’s change of status
hereunder and shall be subject to Article 3.2.
(c) In the event a LICENSEE provides written notice to VANDERBILT and LICENSEE is terminating
pursuing regulatory approval for the Product.
3.2 Effect of Termination. Upon termination of this Agreement, LICENSEE shall cease all
production and sale of Product except for the production and sale of Product on which production
had begun prior to notice of such termination. LICENSEE may continue to sell such Product for up
to one year after such notice upon payment of royalties accruing thereon, and shall render an
accounting to VANDERBILT of any royalties which may be due. Immediately upon termination all
rights of Licensee, except as expressly stated in this article, shall revert to VANDERBILT.
3.3 Sections 3.2, 3.4, 5.1, Article 6, Article 7, Article 8, Article 9, and Section 10.8 of the
agreement shall survive termination.
3
4. CONSULTING AGREEMENTS
4.0 Consulting Agreements. In the event LICENSEE desires to have a Consulting Agreement
with Xx. Xxxxxxx, any such Consulting Agreement will be separate and apart from this Agreement, and
in accord with VANDERBILT policy and procedures.
5. ROYALTIES AND [***]
5.0 [***]
5.1 Royalties. Commencing on the effective date of this Agreement, LICENSEE agrees to pay
VANDERBILT at the rate of [***] percent of Net Sales of Products sold to third parties.
5.2 Schedule of Payment. LICENSEE further agrees to pay royalties on a quarterly basis
based on LICENSEE’s fiscal quarter and payments shall be due within forty-five (45) days after the
completion of the fiscal quarter. Each such payment shall be accompanied by a statement for the
period covered by such royalties showing total number or volume of Products sold, and total
royalties due, and identified as Net Sales within U.S. or non-U.S. This statement is to be
certified as accurate by a responsible officer of LICENSEE.
5.3 [***]
5.4 Reports. LICENSEE shall provide written annual reports within [***] after December 31
of each calendar year which shall include but not be limited to: reports of progress on research
and development, regulatory approvals, manufacturing, marketing and sales during the preceding
twelve (12) months as well as plans for the coming year. LICENSEE shall promptly notify VANDERBILT
if any changes in the marketplace or in LICENSEE’s financial condition or business aims suggest
commercialization will not occur within three (3) years from the date hereof.
5.5 Records. LICENSEE shall maintain complete and accurate records sufficient to enable
accurate calculation of royalties due VANDERBILT under this Agreement. LICENSEE shall, at
VANDERBILT’s request and expense, provide certified statements from LICENSEE’s auditors, concerning
royalties due pursuant to this Agreement. Once a calendar year, VANDERBILT shall have the right to
select a certified public accountant to inspect, on reasonable notice and during regular business
hours, the records of LICENSEE to verify LICENSEE’s statements and royalty payments pursuant to
this Agreement. The entire cost for such inspection shall be borne by VANDERBILT, unless there is
a discrepancy greater than 5% in VANDERBILT’s favor, in which case LICENSEE shall bear the entire
cost of the inspection. Records shall be preserved by LICENSEE for three (3) years for inspection
by VANDERBILT.
5.6 If this Agreement is not terminated in accordance with other provisions hereof, LICENSEE’s
obligation to pay royalties hereunder shall continue as long as Product is being distributed by
LICENSEE.
4
5.7 The royalty on sales in currencies other than U.S. Dollars shall be calculated using the
appropriate exchange rate for such transactions quoted by CITICORP BANK (NEW YORK) foreign exchange
desk on the last banking day of each calendar quarter. Royalty payments to VANDERBILT shall be in
U.S. Dollars.
5.8 In the event that LICENSEE is acquired by a third party or enters into a joint venture with a
third party, or in any other way transfers all of its assets, including this License to a third
party, all obligations of this License, including the foregoing royalty terms, shall be binding
upon the party acquiring this License.
6. CONFIDENTIALITY
6.0 It may be necessary for one party to disclose to the other party certain confidential or
proprietary information, including business plans and marketing strategies. In such event, the
receiving party agrees to preserve such identified information as confidential. The obligation of
confidentiality shall not apply to information which:
(a) is now in the public domain or which becomes generally available to the public through no
fault of the receiving party; or
(b) is already known to, or in the possession of, the receiving party prior to disclosure by
the disclosing party as can be demonstrated by documentary evidence; or
(c) is disclosed on a non-confidential basis from a third party having the right to make such
a disclosure; or
(d) is independently developed by the receiving party as can be demonstrated by documentary
evidence.
6.1 Term. The confidentiality obligations of this Article shall continue for a period of
five (5) years beyond the termination of this Agreement.
5
7. INFRINGEMENT
7.0 Products Infringing Third Parties. Each party shall promptly notify the other if any
legal proceedings are commenced or threatened against either party or any purchaser of a Product
sold by LICENSEE on the ground that the manufacture, use, sale or possession of the Product is an
infringement of a third party’s patent or other intellectual property rights. LICENSEE shall, at
its own expense, conduct all suits brought against it as a result of the exercise of the rights
granted hereunder, and VANDERBILT shall, at the request and expense of LICENSEE, give LICENSEE all
reasonable assistance in any such proceedings. Payment of any amounts which may be recovered by
such third party by way of judgment, award, decree, or settlement that resulted from infringement
of third party patent rights or other rights by a Product, including attorneys’ fees and other
costs shall be the sole responsibility of LICENSEE. LICENSEE agrees not to settle or compromise any
action, suit or proceeding without the consent of VANDERBILT.
8. WARRANTIES AND INDEMNITIES
8.0 Nothing in this Agreement shall be constructed as:
(a) a warranty or representation by VANDERBILT that anything made, used, sold, or otherwise
disposed of through the license granted herein is or will be free from infringement of patents
rights of third parties;
(b) an obligation by VANDERBILT to bring or prosecute actions or suits against third parties
for infringement;
(c) Granting by implication, estoppel, or otherwise any licenses under patents of VANDERBILT.
8.1 To the best of its knowledge and belief, VANDERBILT hereby represents and warrants that it is
the sole owner of the Data and has the right to grant the license to the Data provided herein and
that to the best of its knowledge and belief after due inquiry, no rights of patients or other
persons are or will be infringed by the license granted to LICENSEE. VANDERBILT further represents
and warrants that the Data is both accurate and complete and includes all information and data
relating to intravenously administered ibuprofen to which VANDERBILT holds title. VANDERBILT also
represents and warrants that it has full right, title, and authority to enter into this Agreement
and that VANDERBILT is not under any obligation resulting from any contract or arrangement, to any
person, firm, or corporation, which is inconsistent or in conflict with this Agreement.
8.2 (a) LICENSEE shall indemnify, defend and hold harmless VANDERBILT and its trustees, officers,
faculty, staff, employees, students, agents and representatives, and their respective successors,
heirs and assigns (the “Indemnities”), against any liability, damage, loss or expenses (including
reasonable attorneys’ fees and expense of litigation) incurred by or imposed upon the Indemnities
or any one of them in connection with any claims, suits, actions, demands, or judgments arising out
of any theory of law (including, but not limited
6
to, actions in the form of tort, warranty, or strict liability) arising from LICENSEE’s use of the
Data pursuant to any right or license granted under this Agreement. Such indemnity obligation
shall include claims and expenses related to infringement of a third party’s rights by the Product.
(b) LICENSEE agrees, at its own expense, to provide attorneys reasonably acceptable to
VANDERBILT to defend against any actions brought or filed against any party indemnified hereunder
with respect to the subject of indemnity contained herein, whether or not such actions are
rightfully brought.
(c) VANDERBILT shall indemnify, defend and hold harmless LICENSEE and its officers, directors,
employees, agents, and shareholders, notwithstanding termination of this Agreement, against any
liability, damage, loss, or expenses (including reasonable attorney’s fees) incurred by or imposed
in connection with any claims, suits, actions, demands or judgments arising out of any theory of
law (including, but not limited to, actions in the form of tort, warranty, or strict liability)
arising from default under any provision of this Agreement by VANDERBILT.
8.3 VANDERBILT MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND EXPRESS OR IMPLIED,
OTHER THAN AS EXPRESSLY STATED HEREIN. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT USE OF A PRODUCT WILL NOT INFRINGE ANY
PATENT, COPYRIGHT, TRADEMARK, OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
8.4 Regarding the indemnity and hold harmless provisions, under Paragraph 8.2, VANDERBILT shall
give prompt written notice to LICENSEE of the commencement of any action, suit, or proceeding for
which indemnification may be sought, and LICENSEE, through counsel reasonably satisfactory to
VANDERBILT shall assume the defense thereof; provided, however, that VANDERBILT shall be entitled
to participate in any such action, suit, or proceeding with counsel of its own choice, but at its
own expense. If LICENSEE fails to assume the defense within ninety (90) days of receipt of written
notice of the action, suit, or proceeding, VANDERBILT may assume such defense and the reasonable
fees and expenses of its attorneys will be covered by the indemnity provided for in Paragraph 8.2.
No such action, suit, or proceeding shall be compromised or settled in any manner which might
adversely affect the interests of VANDERBILT without the prior written consent of VANDERBILT.
Notwithstanding anything in this Paragraph to the contrary, LICENSEE shall not, without the written
consent of VANDERBILT, which consent shall not be unreasonably withheld:
(a) Settle or compromise any action, suit, or proceeding or consent to the entry of any
judgment which does not include as an unconditional term thereof the delivery by the claimant or
plaintiff to VANDERBILT of a written release from all liability in respect of such action, suit, or
proceeding; or
(b) Settle or compromise any action, suit, or proceeding in any manner which may adversely
affect VANDERBILT.
7
8.5 Insurance. (a) Beginning at the time as any Product is being commercially distributed
or sold by LICENSEE or agent of LICENSEE, LICENSEE or such other, shall make commercially
reasonable efforts to procure and maintain comprehensive general product liability and tort
liability insurance in amounts not less than $5,000,000 per incident and $5,000,000 annual
aggregate and name the Indemnities as additional insureds. Such comprehensive general liability
insurance shall provide (i) product liability coverage and (ii) broad form contractual liability
coverage for LICENSEE’s indemnification under this Agreement. If LICENSEE elects to self-insure or
otherwise finds it necessary to self-insure all or part of the limits described above, such
self-insurance program must be reasonably acceptable to VANDERBILT. LICENSEE agrees that no amount
greater than the sum of $250,000 shall be deductible under LICENSEE’s primary coverage for
VANDERBILT and LICENSEE against any claims or suits arising from alleged defects in Products. The
minimum amounts of insurance coverage required shall not be construed to create or limit LICENSEE’s
liability with respect to its indemnification under this Agreement.
(b) LICENSEE represents and warrants that it will make commercially reasonable efforts to
acquire its product liability and general tort liability is of the occurrence-based rather than
claims-made type. Within thirty (30) day after the date of the first commercial sale of a Product
hereunder, LICENSEE shall provide VANDERBILT with a certificate or certificates of insurance
evidencing that VANDERBILT has been named as an additional insured party and evidencing the
insurer(s) is required to notify VANDERBILT in writing at least thirty (30) days in advance of any
termination of the policy or certificate, or any modification that would cause LICENSEE no longer
to be in compliance with the provisions of this Article, or would cause the representation and
warranties set forth above in this Article no longer to be true, such written notification to
specify the reason for such termination, the nature of the proposed modification, as the case may
be. It is expressly agreed by the parties that the provisions of this Article regarding insurance
shall in no way limit LICENSEE’s indemnity obligations, except to the extent that LICENSEE’s
insurer(s) actually pays VANDERBILT amounts for which VANDERBILT is entitled to be indemnified
under this Agreement, nor shall VANDERBILT have any obligation to pursue any insurer as a
precondition to its rights to be indemnified by LICENSEE. As used in this Article, the term
“VANDERBILT” shall include VANDERBILT, and its officers, directors, agents and employees. If
LICENSEE does not make commercially reasonable efforts to obtain replacement insurance within such
thirty (30) day period specified above, VANDERBILT shall have the right to terminate this Agreement
effective at the end of such thirty (30) day period without notice or any additional waiting
periods.
(c) LICENSEE shall maintain such comprehensive general product liability and tort liability
insurance or self-insurance beyond the expiration or termination of this Agreement during (i) the
period that any product relating to, or developed pursuant to, this Agreement is being commercially
distributed or sold by LICENSEE or agent of LICENSEE and (ii) a period not less than the statute of
limitations for product liability claims in the state in which the product is being used.
8
9. USE OF VANDERBILT’S NAME
9.0 LICENSEE agrees not to identify VANDERBILT or to use the name of VANDERBILT, its faculty,
employees, or students, or any trademark, service xxxx, trade name, or symbol of VANDERBILT, or
that is associated with any of them, in promotional advertising or other similar materials without
VANDERBILT’s written consent, except as required by governmental authority. LICENSEE may, without
prior consent, refer to VANDERBILT as LICENSOR of the Data submitted in support of marketing
approval for Product in a business plan, fund raising material or the like. All other uses of
VANDERBILT’s name shall be made only after prior approval.
9.1 VANDERBILT agrees not to identify LICENSEE or to use the name of LICENSEE’s officers,
employees, or any trademark, service xxxx, trade name or symbol of LICENSEE without the written
consent of LICENSEE, except as may be required by governmental authority or as necessary in the
normal course of VANDERBILT’S business operations.
10. TERMS AND CONDITIONS
10. Manner of Payment. All payments hereunder shall be made by check to VANDERBILT. Where
required to do so by applicable law or treaty, LICENSEE shall withhold taxes required to be paid
to a taxing authority on account of such income to VANDERBILT, and LICENSEE shall furnish
VANDERBILT with satisfactory evidence of such withholding and payment in order to permit
VANDERBILT to obtain a tax credit or other relief as may be available under the applicable law or
treaty.
10.1 Provisions Contrary to Law. In performing this Agreement, the parties shall comply
with all applicable laws and regulations. In particular, it is understood and acknowledged that
the transfer of certain commodities and technical data is subject to United States laws and
regulations controlling the export of such commodities and technical data, including all Export
Administration Regulations of the United States Department of Commerce. These laws and regulations
among other things, prohibit or require a license for the export of certain types of technical
data to certain specified countries. LICENSEE hereby agrees and gives written assurance that it
will comply with all United States laws and regulations controlling the export of commodities and
technical data, that it will be solely responsible for any violation of such by LICENSEE or its
Affiliates, and that it will defend and hold VANDERBILT harmless in the event of any legal action
of any nature occasioned by such violation.
Nothing in this Agreement shall be construed so as to require the violation of any law, and
wherever there is any conflict between any provision of this Agreement and any law the law shall
prevail, but in such event the affected provision of this Agreement shall be affected only to the
extent necessary to bring it within the applicable law.
10.2 Notices. Any notice may be initially given by facsimile with confirmation required or
permitted to be given by this License by postpaid, first class, registered or certified mail
addressed as set forth below unless changed by notice so given:
9
For LICENSEE:
|
For VANDERBILT: | |
| Office of Technology Transfer | ||
000 00xx Xxx. Xxxxx, Xxxxx 000
|
VANDERBILT University | |
Xxxxxxxxx, Xxxxxxxxx 00000
|
0000 00xx Xxxxxx, X., Xxxxx 000 | |
Fax: 000-000-0000
|
Xxxxxxxxx, XX 00000 | |
| Fax: 000-000-0000 | ||
With a copy to: |
||
Xxxxxx & Xxxxxxxxxxx, P.A. |
||
000 Xxxxxx Xxxxxx, 00xx Xxxxx |
||
Xxxxxxxxx, Xxxxxxxxx 00000 |
||
Attn: Xxxxxx X. Xxxxx, Esq. |
||
Fax: 000-000-0000 |
Such notice shall be effective upon receipt by the party to whom notice is sent.
10.3 Dispute Resolution. The parties acknowledge and agree that they have entered into this
agreement with the expectation of a long-term, mutually beneficial relationship. However, should
disagreement arise regarding obligations imposed on the parties be this Agreement, it is agreed
that the parties will, in good faith, promptly attempt to reach an amicable resolution of such
disagreement.
10.4 Force Majeure. Neither party to this License Agreement shall be liable for delay or
failure in the performance of any of its obligations hereunder if such delay or failure is due to
causes beyond its reasonable control, including, without limitation, acts of God, fires,
earthquakes, strikes, and labor disputes, acts of was, civil unrest, or intervention of any
governmental authority, but any such delay or failure shall be remedied by such party as soon as is
reasonably possible. Failure to make timely royalty payments shall not be excused by Force
Majeure.
10.5 Assignments. Except in connection with the sale of all or substantially all of the
assets of either party, this Agreement may not be assigned by either party without the prior
written consent of the other party, which consent shall not be unreasonably withheld. The parties
hereto agree that each is acting as an independent contractor and not as an agent of the other or
as joint ventures.
10.6 Waivers and Modifications. The failure of any party to insist on the performance of
any obligation hereunder shall not act as a waiver of such obligation. No waiver, modification,
release, or amendment of any obligation under this Agreement shall be valid or effective unless in
writing and signed by both parties hereto.
10.7 Successors in Interest. This Agreement shall inure to the benefit of and be binding on
the parties’ permitted assigns, successors in interest, and subsidiaries.
10
10.8 Choice of Law and Jurisdiction. This Agreement is subject to and shall be construed
and enforced in accordance with the laws of the U.S.A., and Tennessee. Any action on any dispute
arising out of this Agreement shall be tried in Davidson County, and the parties consent to the
jurisdiction of the state and federal courts there.
10.9 Entire Agreement. This Agreement constitutes the entire agreement between the parties
as to the subject matter hereof, and all prior negotiations, representations, agreements and
understandings are merged into, extinguished by and completely expressed by this Agreement.
11
IN WITNESS WHEREOF, the parties have duly executed this Agreement on the date(s) written below.
| LICENSEE | VANDERBILT UNIVERSITY | |||||||||
By:
|
/s/ X.X. Xxxxxx | By: | /s/ Xxxxx X. Xxxxxxxx | |||||||
| X.X. Xxxxxx | Xxxxx X. Xxxxxxxx, Ph.D. | |||||||||
Title:
|
President | Title: | Director, Office of Technology Transfer | |||||||
Date:
|
May 28, 1999 | Date: | June 4, 1999 | |||||||
| ACKNOWLEDGED AND AGREED | ||||||||||
By:
|
/s/ Xxxxxx X. Xxxxxxx, M.D. | |||||||||
| X.X. Xxxxxx | ||||||||||
Title:
|
Professor of Medicine | |||||||||
Date:
|
6/2/99 | |||||||||
12
