EXHIBIT 10.49
LICENSE AGREEMENT
THIS LICENSE AGREEMENT is made and entered into this 23rd day of
August, 1999 between THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL having an
address at CB #4105, 000 Xxxxx Xxxx, Xxxxxx Xxxx, X.X. (hereinafter referred to
as University) and Renaissance Cell Technologies, Inc., a corporation organized
and existing under the laws of Delaware and having an address at X.X. Xxx 00000,
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000 (hereinafter referred to as Licensee).
W I T N E S S E T H
WHEREAS, University owns and controls inventions known as[*], and [*]
(hereafter jointly, "Bioreactor Inventions");
WHEREAS, University owns and controls inventions known as [*]
(hereafter "Progenitor Inventions"),(hereafter Bioreactor Inventions and
Progenitor Inventions may be referred to jointly as "Inventions");
WHEREAS, the Bioreactor Inventions were developed by Xx. Xxxxxxx
Xxxxxxxxx and the Progenitor Inventions were developed by Xx. Xxxx Xxxx et. al.
(hereafter, "Inventors"), of the University in part under the Sponsored Research
Agreement between the parties dated July 1, 1997 (the "Sponsored Research
Agreement"); and
WHEREAS, Licensee was granted an option to license any inventions that
resulted from the Sponsored Research Agreement, and exercised that option with
respect to the Inventions on December 7, 1998; and
WHEREAS, University desires to facilitate a timely transfer of its
information and technology concerning the Inventions for the ultimate benefit of
the public and this transfer is best accomplished by the grant of this license;
NOW, THEREFORE, for and in consideration of the covenants, conditions,
and undertakings hereinafter set forth, it is agreed by and between the parties
as follows:
1. Definitions
1.1 "Sponsored University Technology" means any unpublished research
and development information, unpatented inventions, know-how, and technical data
in the possession of the University prior to the effective date of this
Agreement or which comes into the possession of University resulting from
research conducted by the inventors of the Patent Rights as a result of, and
during the term of the Sponsored Research Agreement which relates to and is
necessary for the practice of the Inventions and Improvements and which
University has the right to provide to Licensee.
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
l.2 "Licensed Products" means any method, procedure, product, service,
or component part thereof whose manufacture or sale includes any use of
University Technology or Patent Rights.
1.3 "Patent Rights" means any U.S. patents and/or patent applications
covering the Inventions and Improvements owned or controlled by University prior
to or during the term of this Agreement and which University has the right to
provide to Licensee, as well as any continuations, continuations in part,
divisionals, provisionals, continued prosecution applications, or reissues
thereof, and any foreign counterpart of any of the foregoing.
1.4 "Net Sales Price" means the invoiced sales price of Licensed
Products, less the following sums actually paid or credited by Licensee as shall
be detailed in Licensee's reports made pursuant to Paragraph 3.3 of this
Agreement: (a) sales taxes or other taxes separately stated on the invoice, (b)
shipping and insurance charges and (c) quantity, trade or cash discounts allowed
in amounts customary in the trade.
1.5 "Net Sales" means the total Net Sales Price of Licensed Products,
after deducting actual allowances for returned or defective goods. Licensed
Products will be considered sold when billed out, or when delivered or paid for
before delivery, whichever first occurs.
1.6 "Licensed Territory" means the entire world.
1.7 "Licensed Field" means, and is limited to, the practice of the
Inventions for all uses and fields.
1.8 "IDE" means Investigational Device Exemption Application or its
foreign equivalent thereto filed on a Licensed Product.
1.9 "IND" means Investigational Exemption for New Drug Application or
its foreign equivalent thereto filed on a Licensed Product.
1.10 "PMA" means Premarket Approval Application or its foreign
equivalent thereto filed on a Licensed Product.
1.11 "PLA" means a Product License Application or its foreign
equivalent thereto filed on a Licensed Product.
1.12 "NDA" means a New Drug Application or its foreign equivalent
thereto filed on a Licensed Product.
1.13 "Affiliate" means any person or entity which directly or
indirectly owns or controls 50% or more of the outstanding voting securities of
Licensee or any corporation or other business entity of which 50% or more of the
outstanding voting securities or other ownership interests are owned or
controlled, directly or indirectly, by Licensee.
1.14 "Non-Sponsored University Technology" means any unpublished
research and development information, unpatented inventions, know-how, and
technical data in the possession
of the University prior to the effective date of this Agreement or which comes
into the possession of University during the term of this Agreement which
relates to and is necessary for the practice of the Inventions and which
University has the right to provide to Licensee. (Hereafter Non-Sponsored
University Technology and Sponsored University Technology may be referred to
jointly as "University Technology".)
1.15 "Sales Year" shall mean as to a specific Licensed Product, the
period beginning on the date of first commercial sale of that Licensed Product
and extending for twelve months thereafter, and each successive twelve-month
period for the life of this Agreement.
1.16 "Improvements" shall mean any improvements or inventions made
subsequent to the date of this License Agreement for the identification,
isolation, cryopreservation, purification, expansion, or culture of hepatic
progenitor cells and their use for treating liver failure and liver dysfunction,
and which result from the Sponsored Research Agreement. Improvements or
modifications to the Inventions that are included in the issued patents or
patent applications covering the Inventions shall not be considered
Improvements.
2. Grant of License and Term
2.1 University grants to Licensee in the Licensed Territory an
exclusive right and license to use Sponsored University Technology in the
Licensed Field, subject to University's reservation of rights under paragraph
9.1. For purposes of this paragraph, "exclusive" means that University will not
knowingly license any other third party the rights to such Sponsored University
Technology. University also grants to Licensee in the Licensed Territory a
non-exclusive right and license to use Non-Sponsored University Technology, in
the Licensed Field. Each license granted in this paragraph 2.1 is subject to all
the terms and conditions of this Agreement. Licensee may grant, subject to
University prior written approval, which approval shall not be unreasonably
withheld, sublicenses of its rights under this paragraph 2.1.
2.2 University grants to Licensee to the extent of the Licensed
Territory, an exclusive license, with the right to grant sublicenses, under the
Patent Rights and the right to make, use and sell Licensed Products in the
Licensed Field, upon the terms and conditions set forth herein. Licensee may
grant, subject to University prior written approval, which approval shall not be
unreasonably withheld, sublicenses of its rights under this paragraph.
2.3 Any license granted herein is for a term beginning on the date of
execution of this Agreement and, unless terminated sooner as herein provided,
ending at the expiration of the last to expire patent included in the Patent
Rights, or if no patents mature from said Patent Rights, such license shall
terminate 15 years from the date of its commencement, at which time Licensee's
license to use the Sponsored University Technology shall be fully-paid.
2.4 Licensee agrees not to use University Technology and Patent Rights
for any purpose other than that set forth in Paragraphs 2.1 and 2.2 without the
prior written consent of University. Licensee shall not disclose any unpublished
University Technology or patent applications included in Patent Rights furnished
by University pursuant to Paragraph 2.1 and 2.2 above to third parties during
the term of this Agreement or any time thereafter, provided, however, that
disclosure may be made of any such patent applications and University Technology
at any time:
(1) with the prior written consent of University, or (2) after the
same shall have become public through no fault of Licensee. Licensee shall use
the same standard of care to protect University Technology and University patent
applications as it uses to protect its own confidential information, and shall
limit disclosure of such information to those of its employees who have an
actual need to know and who have a written obligation to protect the
confidentiality of such information which is substantially the same as the
agreement contained herein. Notwithstanding other provisions of this Paragraph
2.4 to the contrary, Licensee may disclose to its Affiliates, consultants,
collaborators, potential collaborators or other third parties to be engaged by
Licensee in the development or commercialization of Licensed Products, the
University Technology and patent applications without prior written consent of
University, only if those parties have signed confidentiality agreements with
Licensee on terms which are substantially the same as those contained in this
Paragraph 2.4. Licensee will promptly forward to University copies of all such
agreements.
2.5 The provisions of Paragraph 2.4 shall remain in effect for a period
of five years beyond the termination of this Agreement.
2.6 Notwithstanding the foregoing, any and all licenses granted
hereunder are subject to the rights of the United States Government if any which
arise out of its sponsorship of the research which led to the Inventions.
2.7 Pursuant to Paragraph 2.2 above, Improvements shall in each case be
incorporated in this Agreement by way of separate letter amendment to this
Agreement signed by authorized representatives of both parties.
3. License Fee, Milestone Payments and Royalties
3.1 (a) Licensee shall pay to University a license issue fee
for the Progenitor Inventions in the amount of [ * ]
dollars ($[ * ]) for [ * ] and [ * ] dollars ($[
* ]) for [ * ], and for the Bioreactor Inventions in
the amount of [ * ] dollars ($[ * ]) for a total license issue
fee of [ * ] dollars ($[ * ]), payable
within thirty (30) days of execution of this Agreement. Licensee further agrees
to pay University a [ * ] dollar ($[ * ]) license
fee for each Improvement licensed hereunder, payable within thirty (30) days of
execution of a letter amendment pursuant to Paragraph 2.7 above.
(b) Licensee will also reimburse the University for all past
and future costs (including attorney's fees) arising out of the patenting of the
Inventions pursuant to Article 10 of this Agreement to the extent not paid by
Licensee prior to the date of this Agreement. Reimbursement of patenting costs
shall be due upon monthly xxxxxxxx from University.
(c) Licensee shall pay to University the following milestone
payments within thirty (30) days after each milestone is achieved.
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
With respect to Licensed Products incorporating or otherwise
using the Bioreactor Inventions:
(i) $[ * ] per product for the initial
IDE or equivalent approval;
(ii) $[ * ] per product at the initiation
of the initial Phase III clinical trials or its
equivalent;
(iii) $[ * ] per product for the initial
PMA, PLA or equivalent approval in the first country
where such approval is received.
With respect to Licensed Products incorporating or otherwise
using the Progenitor Inventions:
(i) $[ * ] per product for the initial
IND or equivalent approval;
(ii) $[ * ] per product at the initiation
of the initial Phase III clinical trials or its
equivalent;
(iii) $[ * ] per product for the initial
PMA, PLA or its equivalent approval in the first
country where such approval is received.
With respect to this Section 3.1 only, different indications
for native hepatic progenitor cells are not separate products.
(d) If an IND or equivalent filing for a Licensed Product
includes one or more Improvements that are covered by a valid claim of a US
patent(s) included in the Patent Rights, then an additional license payment of
[ * ] dollars ($[ * ]) for each Improvement included in that Licensed Product
shall be immediately payable to University. If the US patent on an Improvement
has not issued when the IND or equivalent filing for the Licensed Product
including such Improvement is made, then the payment will be owed upon issuance
of such US patent. For example, if an IND is filed for a Licensed Product that
includes two patented Improvements, then a [ * ] dollar ($[ * ]) license payment
will be made to University, and no subsequent [ * ] dollar license payments
shall be owed for subsequent IND filings of other Licensed Products that include
the aforementioned two Improvements.
The license issue fee, the reimbursement of patenting costs and the
milestone payments shall all be non-refundable and shall not be a credit against
any other amounts due hereunder except as may be provided for elsewhere in this
Agreement.
3.2 Beginning on the effective date of this Agreement and continuing
for the life of this Agreement, Licensee will pay University a running royalty
of all Net Sales of the Licensed Product(s). Subject to Section 5.3, the royalty
rate will be [ * ]% of the first $[ * ] of annual Net Sales of a Licensed
Product; [ * ]% of the portion of annual
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
Net Sales between $[ * ] and $[ * ]; and [ * ]% of
the portion of annual Net Sales in excess of $[ * ].
This schedule will be applied separately for Net Sales of Licensed
Products based on each of the Progenitor Inventions and Bioreactor Inventions.
However, if a Licensed Product consists of the Progenitor Inventions and either
a Bioreactor Invention or a component or service that does not bear a royalty,
the term "Net Sales" for purposes of determining the royalties payable with
respect to each Invention shall mean that portion of the invoiced price of the
Licensed Product represented by or attributable to such Invention on the
invoice, or the cost of goods sold, if the invoiced price is not separately
available for each Invention. For example, if a Licensed Product consists of a
bioartificial liver device, and the Progenitor Inventions contributes 50% of the
value of such product, and the Bioreactor Invention contributes 25% of the
value, the royalties for each Invention shall be calculated based on 50% of the
Net Sales of such Licensed Product and 25% of such Net Sales, respectively.
3.3 Licensee agrees to make semi-annual written reports to University
within 30 days after the first days of each January and July during the life of
this Agreement and as of such dates, stating in each such report the number,
description, and aggregate Net Selling Prices of Licensed Products sold or
otherwise disposed of during the preceding six calendar months and upon which
royalty is payable as provided in Article 3.2 hereof. The first such report
shall include all such Licensed Products so sold or otherwise disposed of prior
to the date of such report. Until Licensee has achieved a first commercial sale
of a Licensed Product a report shall be submitted by Licensee at the end of each
January and July after the effective date of this Agreement and will include a
full written report describing Licensee's technical and other efforts made
towards such first commercial sale for all Licensed Products under development.
To the extent permitted by the NC Public Records Act, N.C.G.S. Ch. 132A,
University agrees to keep all such reports confidential.
3.4 Concurrently with the making of each such report, Licensee shall
pay to the University royalties at the rate specified in Article 3.2 of this
Agreement on the Licensed Products included therein.
3.5 If in any Sales Year for a Licensed Product based on each of
the Progenitor Inventions and Bioreactor Inventions, during the term of this
Agreement, total amounts payable under Paragraph 3.2 hereof are less than the
minimum amount indicated in the Schedule below corresponding to such Sales Year,
Licensee shall pay the University within thirty (30) days after the end of such
Sales Year, the difference between the amounts payable for such calendar year
and said minimum amount.
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
SCHEDULE
Date of First Minimum Amounts
------------- ---------------
Commercial Sale or Use (X) Progenitor Inventions Bioreactor Inventions
-------------------------- --------------------- ---------------------
X $[ * ] $[ * ]
X+12 months and X+24 months $[ * ] $[ * ]
X+36 months and all subsequent $[ * ] $[ * ]
12-month periods
As an example, if the first commercial sale of a Licensed Product based
on the Progenitor Inventions occurs June 1, 2003, then the minimum annual
royalty obligation of $[ * ] would be owed for the Sales Year commencing June
1, 2004.
3.6 Should this Agreement terminate or expire during a Sales Year, the
minimum royalty under paragraph 3.5 for such portion of a year shall be
determined by multiplying the minimum royalty set forth in said paragraph for
the Sales Year in which this Agreement terminates or expires, by a fraction, the
numerator of which shall be the number of days during such Sales Year for which
this agreement shall be in effect and the denominator of which shall be 365.
3.7 In the event of default in payment of any payment owing to
University under the terms of this Agreement, and if it becomes necessary for
University to undertake legal action to collect said payment, Licensee shall pay
all legal fees and costs incurred by University in connection with a proceeding
resulting in a judgement in favor of University.
3.8 If Licensee has not practiced the Inventions during the calendar
year which precedes April of the year 2013 to the extent of generating earned
royalties under paragraph 3.2 of this Agreement in the amount of $[ * ],
Licensee shall furnish University with an explanation for the failure. If, after
consultation with Licensee, University determines in its sole opinion that
Licensee has not provided a reasonable explanation for the failure, University
may, by written notice to Licensee, terminate this Agreement.
3.9 In partial consideration of the license granted under paragraph 2.2
of this Agreement, Licensee shall issue to University 12,500 shares of fully
vested Common Stock of Licensee within thirty (30) days of execution of this
Agreement.
3.10 The transfer of Common Stock pursuant to Section 3.9 of this
Agreement is made with the University in reliance upon the University's
representation to the Licensee, which the University hereby confirms by
execution of this Agreement, except to the extent the University distributes
part of its Common Stock to the Inventors pursuant to University policy (which
does not require the Inventors to pay any consideration to the University for
such Common Stock), that the Common Stock to be received by the University (the
"Securities") will be acquired for investment for University's own account, not
as a nominee or agent, and not with a view to the resale or distribution of any
part thereof, and that the University has no present intention of selling,
granting any participation in, or otherwise distributing the same, except to the
University
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
of North Carolina Foundation, Inc., for purposes of holding the Securities. By
executing this Agreement, the University further represents that it does not
have any contract, undertaking, agreement, or arrangement with any person to
sell, transfer, or grant participation to such person or to any third person,
with respect to any of the Securities.
3.11 The University has received all the information that it considers
necessary or appropriate for deciding whether to purchase the Securities. The
University further represents that it has had sufficient opportunity to ask
questions and receive answers from the Licensee regarding the terms and
conditions of the offering of the Securities.
3.12 The University acknowledges that it is able to fend for itself,
can bear the economic risk of its investment, and has such knowledge and
experience in financial or business matters that it is capable of evaluating the
merits and risks of the investment in the Securities.
3.13 The University and the Inventors understand that the Securities
are characterized as "restricted securities" under the federal securities laws
in as much as they are being acquired from Licensee in a transaction not
involving a public offering and that under such laws and applicable regulations
such Securities may be resold without registration under the Securities Act of
1933, as amended (the "Act"), only in certain limited circumstances. In this
regard, the University and the Inventors each represent that it is familiar with
SEC Rule 144, as currently in effect, and understands the resale limitations
imposed thereby and by the Act.
4. Diligence Requirement
4.1 Licensee shall use its best efforts to proceed diligently with the
manufacture and sale of Licensed Products and shall earnestly and diligently
offer and continue to offer for sale such Licensed Products, both under
reasonable conditions, during the period of this Agreement.
4.2 In particular, Licensee or its sublicensees, shall meet the
following performance milestones. If Licensee fails to achieve these milestones,
Licensee shall furnish University with an explanation for the failure. If, after
consultation with Licensee, University determines in its sole opinion that
Licensee has not provided reasonable explanation for the failure, University may
terminate this Agreement or convert it to a non-exclusive license, at
University's sole option.
(a) Licensee agrees to extend the Sponsored Research Agreement
for an additional year beyond July 1, 2000 by providing an additional $[ * ] in
research funding to the laboratory of Xx. Xxxx Xxxx at University. Payments
shall be made beginning July 1, 2000.
(b) With respect to the Bioreactor Inventions:
(i) [ * .]
(ii) [ * .]
(iii) [ * .]
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
(c) With respect to the Progenitor Inventions:
(i) [ * .]
(ii) [ * .]
(iii) [ * .]
5. Sublicenses
5.1 Subject to this Article 5, Licensee may grant sublicenses of its
rights under Paragraphs 2.1 and 2.2 above.
5.2 Any sublicense granted pursuant to this Article shall be in
accordance with the terms and conditions of this Agreement. Licensee shall
provide University with a copy of all sublicense agreements within thirty (30)
days of execution.
5.3 University shall receive royalties on both sublicensee Net Sales of
Licensed Products and any other license income received by Licensee from any
sublicensees, as if they were Net Sales made by Licensee subject to Paragraph
3.2; provided, however, that the royalty paid to University will not exceed
[ * ]% of the royalty received by Licensee from its sublicensee, subject to a
minimum royalty paid to University of [ * ]% of sublicensee annual Net Sales;
and provided, further, that the term "license income" excludes amounts received
by Licensee which constitute (i) payments made, at fair market value in
arms-length transactions, for the performance of research or development
activities to the extent that such payments are specifically allocated to
develop Licensed Products and reflect overhead rates that are customary in the
biotechnology industry, (ii) payments to Licensee for the manufacture of the
Licensed Products, (iii) payments to Licensee for the performance by Licensee of
consulting or other services related to the development of Licensed Products,
such as the conduct of preclinical and clinical studies of the Licensed
Products; and (iv) payments made at fair market value in arms-length
transactions representing equity investments in Licensee or the proceeds of debt
instruments; (v) payments representing reimbursement of expenses, such as for
patent costs and fees.
5.4 Licensee shall pay to University, within thirty (30) days of
receipt from sublicensee, all royalty or other payments due to University under
Paragraph 5.3.
6. Cancellation by University
6.1 It is expressly agreed that, notwithstanding the provisions of any
other paragraph of this contract, if Licensee should fail to deliver to
University any royalty at the time or times that the same should be due to
University or if Licensee should in any material respect violate or fail to keep
or perform any covenant, condition, or undertaking of this Agreement on its part
to be kept or performed hereunder, then and in such event University shall have
the right to cancel and terminate this Agreement, and the license herein
provided for, by written notice to Licensee if
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
Licensee has failed to cure any such breach within 30 days of receipt of written
notice from University describing such breach. Licensee's right to cure a breach
during the cure periods specified above will apply only to the first two
breaches occurring within any twenty-four month period and properly noticed
under terms of this Agreement, regardless of the nature of those breaches. Any
subsequent material breach by Licensee will entitle University to terminate this
Agreement upon proper notice.
6.2 Alternatively, should Licensee be in breach or default as set forth
above, and should University be in a position where it could rightfully
terminate this Agreement, then in its sole discretion, University may convert
this exclusive license to a non-exclusive license upon giving notice of such
decision to Licensee.
6.3 If Licensee should enter into a composition with or assignment for
the benefit of its creditors, then in such event University shall have the right
to cancel and terminate this Agreement, and the license herein provided for, by
written notice to Licensee.
6.4 Any termination or cancellation under any provision of this
Agreement shall not relieve Licensee of its obligation to pay any royalty or
other fees (including attorney's fees pursuant to Article 3.1 hereof) due or
owing at the time of such cancellation or termination.
6.5 In the event of termination under the provisions of Article 6.1 all
sublicenses of Patent Rights and/or University Technology will be assigned to
University, and Licensee will have no further obligations to University with
respect to such sublicenses.
7. Disposition of Licensed Products On Hand Upon Cancellation or Termination
7.1 Upon cancellation of this Agreement or upon termination in whole or
in part, Licensee shall provide University with a written inventory of all
University Technology and Licensed Products in process of manufacture, in use or
in stock. Except with respect to termination pursuant to Paragraph 6.1, Licensee
shall have the privilege of disposing of the inventory of such Licensed Products
within a period of one hundred and eighty (180) days of such termination upon
conditions most favorable to University that Licensee can reasonably obtain.
Licensee will also have the right to complete performance of all contracts
requiring use of the University Technology, Patent Rights (except in the case of
termination pursuant to Paragraph 6.1) or Licensed Products within and beyond
said 180-day period provided that the remaining term of any such contract does
not exceed one year. All Licensed Products which are not disposed of as provided
above shall be delivered to University or otherwise disposed of, in University's
sole discretion, and at Licensee's sole expense.
8. Use of University's Name
8.1 The use of the name of University, or any contraction thereof, in
any manner in connection with the exercise of this license is expressly
prohibited except with prior written consent of University, and except that
Licensee may state that it holds an exclusive license with
the University with respect to the Inventions and that the Inventions were the
result of research sponsored by Licensee, in communications to shareholders and
filings with the FDA, SEC, and other governmental authorities. Licensee will
obtain University's approval of any description beyond the statements permitted
in the preceding sentence; but once any additional description is approved by
University, it may be used for other purposes without further review and
approval.
9. University Use
9.1 It is expressly agreed that, notwithstanding any provisions herein,
University is free to use University Technology, Patent Rights and Licensed
Products for its own research, public service, teaching and educational purposes
without payment of royalties. Furthermore, University shall be free to publish
University Technology, as it sees fit; however, during the term of the Sponsored
Research Agreement between the parties, all publications of University
Technology shall be subject to Article 6 of that agreement.
10. Patents and Infringements
10.1 University shall, at Licensee's expense, diligently prosecute and
maintain the United States patents comprising Patent Rights using mutually
agreed upon patent counsel. The parties shall cooperate in the filing and
prosecution of the Patent Rights. University shall provide Licensee (either
directly or through patent counsel) with copies of all relevant documentation so
that Licensee may be informed and apprised of the continuing prosecution and
shall have an opportunity to review and comment on filings in advance. Licensee
will keep this documentation confidential in accordance with paragraph 2.4
hereof. University shall give due consideration to comments of Licensee related
to patent prosecution, including suggestions for amending any patent application
to include claims reasonably requested by Licensee to protect the Licensed
Products. University agrees, subject to Section 6 "Publication" of the Sponsored
Research Agreement, to treat all such documentation as confidential.
10.2 As regards filing of foreign patent applications corresponding to
the U.S. applications described in paragraph 10.1 above, Licensee shall
designate that country or those countries, if any, in which Licensee desires
such corresponding patent application(s) to be filed. Licensee shall pay all
costs and legal fees associated with the preparation and filing of such
designated foreign patent applications and such applications shall be in the
University's name. University may elect to file corresponding patent
applications in countries other than those designated by Licensee, but in that
event University shall be responsible for all costs associated with such
non-designated filings. In such event, Licensee shall forfeit its rights under
this license in the country(ies) where University exercises its option to file
such corresponding patent applications, except that if Licensee is underwriting
the prosecution and maintenance of the Patent Rights in all major markets
(defined as the United States, Canada, Japan, the United Kingdom, France,
Germany, Spain and Italy), University may not license the Patent Rights
prosecuted or maintained by University to third parties. Licensee acknowledges
that the US Government may exercise its right to patent and subsequently
out-license the Bioreactor Inventions Patent Rights in countries which are not
designated by Licensee.
10.3 If the production, sale or use of Licensed Products under this
Agreement by Licensee results in any claim for patent infringement against
Licensee, Licensee shall promptly
notify the University thereof in writing, setting forth the facts of such claim
in reasonable detail. As between the parties to this Agreement, Licensee shall
have the first and primary right and responsibility at its own expense to defend
and control the defense of any such claim against Licensee, by counsel of its
own choice. It is understood that any settlement of such actions that would
affect University's financial rights or would restrict its use of the
Inventions, University Technology, or Patent Rights must be approved by
University. Such approval shall not be unreasonably withheld. University agrees
to cooperate with Licensee in any reasonable manner deemed by Licensee to be
necessary in defending any such action. Licensee shall reimburse University for
any out of pocket expenses incurred in providing such assistance.
10.4 In the event that any Patent Rights licensed to Licensee are
infringed by a third party, Licensee shall have the primary right, but not the
obligation, to institute, prosecute and control any action or proceeding with
respect to such infringement, by counsel of its choice, including any
declaratory judgment action arising from such infringement.
10.5 Notwithstanding the foregoing, and in University's sole
discretion, University shall be entitled to participate through counsel of its
own choosing in any legal action involving the Inventions. Nothing in the
foregoing sections shall be construed in any way which would limit the authority
of the Attorney General of North Carolina.
10.6 University shall cooperate with Licensee in applying for an
extension of the term of any patent included within Patent Rights if appropriate
under the Drug Price Competition and Patent Term Restoration Act of 1984 in the
United States or any other law or regulation in other countries in the
Territory. Licensee shall prepare all such documents, and University agrees to
execute such documents and to take such additional action as Licensee may
reasonably request in connection therewith.
11. Waiver
11.1 It is agreed that no waiver by either party hereto of any breach
or default of any of the covenants or agreements herein set forth shall be
deemed a waiver as to any subsequent and/or similar breach or default.
12. License Restrictions
12.1 It is agreed that the rights and privileges granted to Licensee
are each and all expressly conditioned upon the faithful performance on the part
of the Licensee of every requirement herein contained, and that each of such
conditions and requirements may be and the same are specific license
restrictions.
13. Assignments
13.1 This Agreement is binding upon and shall inure to the benefit of
the University, its successors and assigns. However, this Agreement shall be
personal to Licensee and it is not assignable by Licensee to any other entity
without the written consent of University, which consent shall not be withheld
unreasonably; provided, however, that Licensee, without University's consent,
may assign this Agreement to an entity in which at least a majority of the
voting securities are owned, directly or indirectly, by Licensee at the time of
such assignment, or in the event of Licensee's merger or consolidation with
another company.
14. Indemnity
14.1 Licensee shall indemnify, hold harmless and defend (with counsel
reasonably acceptable to University) University, its trustees, officers,
employees, students, agents and the Inventors (a "University Party") against any
and all losses, liabilities, damages, costs, fees and expenses (including
reasonable attorneys' fees) incurred by a University Party resulting from a
claim, suit or action asserted by a third party arising out of the use,
development, manufacture, promotion, sale or disposition of a Licensed Product
or any other activity related to the practice of the Patent Rights and
University Technology. This indemnification shall include, but is not limited
to, any claims asserted by third parties alleging liability for personal injury
arising out of use of a Licensed Product. Licensee shall not be obligated under
this paragraph 14.1 for any loss or liabilities incurred by a University Party
resulting from such party's gross negligence or willful misconduct.
14.2 University shall indemnify, hold harmless and defend (with counsel
reasonably acceptable to Licensee) Licensee, its officers, directors, employees,
and agents (each, a "Licensee Party") against any and all losses, liabilities,
damages, costs, fees and expenses (including reasonable attorneys' fees)
incurred by a Licensee Party resulting from a claim, suit or action asserted by
a third party arising out of any University Party's gross negligence or willful
misconduct. Licensee acknowledges that University's indemnification obligation
is limited to the extent required by the North Carolina Tort Claims Act.
14.3 As a condition of either party's indemnification obligation, the
party seeking indemnification must promptly notify the indemnifying party in
writing of the existence of the claim or action giving rise to the
indemnification obligation under this Agreement.
15. Insurance
15.1 Licensee is required to maintain in force at its sole cost and
expense, with reputable insurance companies, general liability insurance and
products liability insurance coverage in commercially reasonable amounts to
protect against liability under paragraph 14, above. The University shall have
the right to ascertain from time to time that such coverage exists, such right
to be exercised in a reasonable manner.
16. Independent Contractor Status.
16.1 Neither party hereto is an agent of the other for any purpose.
17. Late Payments
17.1 In the event royalty payments or fees are not received by
University when due, Licensee shall pay to University interest at the annual
rate of interest equal to the prime rate on the first business day of each month
plus 2% on the total unpaid royalties or fees due.
18. Warranties
18.1 University represents that it is an owner of the Inventions and to
the extent of its interest in Inventions has the full right and power to grant
the licenses set forth in this Agreement. Other than the United States
Government, University is not aware of any third party claiming rights to the
Inventions arising through University. University makes no warranties that any
patent will issue on University Technology or Inventions. University further
makes no warranties, express or implied as to any matter whatsoever, including,
without limitation, the condition of any invention(s) or product(s), that are
the subject of this Agreement; or the merchantability or fitness for a
particular purpose of any such invention or product. University shall not be
liable for any direct, consequential, or other damages suffered by Licensee or
any others resulting from the use of the Inventions or Licensed Products.
19. Accounting and Records
19.1 Licensee will keep complete, true and accurate books of account
and records for the purpose of showing the derivation of all amounts payable to
University under this Agreement. Such books and records will be kept at
Licensee's principal place of business for at least three (3) years following
the end of the calendar quarter to which they pertain, and will be open at all
reasonable times for inspection by a representative of University for the
purpose of verifying Licensee's royalty statements, or Licensee's compliance in
other respects with this Agreement. The representative will be obliged to treat
as confidential all relevant matters.
19.2 Such inspections shall be at the expense of University, unless an
underpayment exceeding U.S. $[ * ], or the equivalent, is discovered
in the course of any such inspection, whereupon all costs relating thereto shall
be paid by Licensee.
19.3 Licensee will promptly pay to University the full amount of any
underpayment, together with interest thereon at the maximum rate of interest
allowed by law.
20. Compliance with Laws
20.1 In exercising its rights under this license, Licensee shall fully
comply with the requirements of any and all applicable laws, regulations, rules
and orders of any governmental body having jurisdiction over the exercise of
rights under this license. Licensee further agrees to indemnify and hold
University harmless from and against any costs, expenses, attorney's fees,
citation, fine, penalty and liability of every kind and nature which might be
imposed by reason of any asserted or established violation of any such laws,
order, rules and/or regulations.
21. U.S. Manufacture
21.1 It is agreed that any Licensed Products sold in the United States
shall be substantially manufactured in the United States.
[ * ] Confidential Treatment Requested; Certain Information Omitted and
Filed Separately with the SEC.
22. Notices
22.1 Any notice required or permitted to be given to the parties hereto
shall be deemed to have been properly given if delivered in person, mailed by
first-class certified mail or reputable overnight courier (with proof of
delivery), to the other party at the appropriate address as set forth below or
to such other addresses as may be designated in writing by the parties from time
to time during the term of this Agreement.
UNIVERSITY LICENSEE
Xxxxxxx X. Xxxxx, Ph.D. Renaissance Cell Technologies
Associate Vice Xxxxxxx X.X. Xxx 00000
Xxxxxx xx Xxxxxxxxxx Xxxxxxxxxxx XXX, XX 00000
CB #4105, 000 Xxxxx Xxxx Attn: X. Xxxxxxx Love
UNC-CH
Xxxxxx Xxxx, XX 00000-0000
23. Governing Laws
23.1 This Agreement shall be interpreted and construed in accordance
with the laws of the State of North Carolina.
24. Complete Agreement
24.1 It is understood and agreed between University and Licensee that
this license constitutes the entire Agreement, both written and oral, between
the parties, and that all prior agreements respecting the subject matter hereof,
either written or oral, expressed or implied, shall be abrogated, canceled, and
are null and void and of no effect.
25. Severability
25.1 In the event that a court of competent jurisdiction holds any
provision of this Agreement to be invalid, such holding shall have no effect on
the remaining provisions of this Agreement, and they shall continue in full
force and effect.
26. Survival of Terms
26.1 The provisions of Articles 7, 8, 9, 10, 14, 15, 18, 19, 20, 22,
23, and 24 shall survive the expiration or termination of this Agreement.
IN WITNESS WHEREOF, both University and Licensee have executed this
Agreement, in duplicate originals, by their respective officers hereunto duly
authorized, the day and year first above written. Inventors have likewise
indicated their acceptance of the terms hereof by signing below.
THE UNIVERSITY OF NORTH CAROLINA RENAISSANCE CELL
AT CHAPEL HILL TECHNOLOGIES, INC.
By: /s/ Xxxxxxx X. Xxxxx By: /s/ X. Xxxxxxx Love
------------------------------ --------------------------
Xxxxxxx X. Xxxxx, Ph.D. Name: X. Xxxxxxx Love
Associate Vice Xxxxxxx, ------------------
Technology Development Title: Vice President
Date: August 23, 1999 Date: August 23, 1999
--------------------- ------------------------
INVENTORS:
/s/ Dr. . Xxxx X. Xxxx
--------------------------------
Xx. Xxxx X. Xxxx
August 19, 1999
--------------------------------
Date
/s/ Xx. Xxxxxxx X. Xxxxxxxxx
--------------------------------
Xx. Xxxxxxx X. Xxxxxxxxx
August 19, 1999
--------------------------------
Date
/s/ Dr. Xxxxxxx Xxxxxx
--------------------------------
Dr. Xxxxxxx Xxxxxx
August 19, 1999
--------------------------------
Date
