Bracketed information omitted and filed separately with the Securities and
Exchange Commission
Confidential Treatment Requested Under 17 C.F.R. Sections 200.80(b)(4), 200.83
and 240.24b-2
EXHIBIT 10.8
BIOTECHNOLOGY LICENSING AND TRANSFER AGREEMENT
between
OHIO UNIVERSITY EDISON ANIMAL BIOTECHNOLOGY CENTER
AND
DRUG DEVELOPMENT INVESTMENT CORP.
TABLE OF CONTENTS
PAGE
1. Definitions.................................................... 1
2. License Grant.................................................. 6
3. Technical and Scientific Assistance............................ 9
4. Patent Filing, Maintenance and Extension....................... 10
5. Patent Infringement Action by a Third Party.................... 12
6. Patent Infringement Action Against a Third Party............... 14
7. Compulsory Licensees........................................... 17
8. Payment........................................................ 17
9. Reporting and Record Keeping................................... 21
10. Licensor's Representations and Warranties...................... 22
11. Licensee's Representations and Warranties...................... 23
12. Licensee's Duties.............................................. 24
13. Manufacturing Facility......................................... 25
14. Insurance...................................................... 25
15. Patent Marking................................................. 25
16. Term and Termination........................................... 26
17. Confidential Information....................................... 29
18. New Developments............................................... 32
19. Indemnification................................................ 33
20. Government Requirements and Approvals.......................... 36
21. Force Majeure.................................................. 37
22. Assignments and Affiliates..................................... 37
23. Arbitration.................................................... 38
24. Governing Law.................................................. 38
25. General Provisions............................................. 39
(a) Integrated Agreement...................................... 39
(b) Severability and Reformation.............................. 39
(c) Notices................................................... 39
(d) Construction.............................................. 41
(e) Captions.................................................. 41
(f) Waiver.................................................... 41
(g) Cumulative Remedies....................................... 41
(h) Litigation Costs.......................................... 41
(i) Further Assurances........................................ 41
(j) No Partnership............................................ 42
(k) Confidentiality Pending Effectiveness of Agreement........ 42
(l) Interest on Delinquent Obligations........................ 42
(m) Signatory Authority....................................... 42
(n) Multiple Counterparts..................................... 42
Exhibits
--------
Exhibit A........................................................... 44
Exhibit B........................................................... 45
BIOTECHNOLOGY LICENSING AND TRANSFER AGREEMENT
THIS AGREEMENT, entered into as of the Effective Date (as hereinafter
defined), between. OHIO UNIVERSITY, a state chartered university and its Edison
Animal Biotechnology Center, a department of OHIO UNIVERSITY, currently located
at 000 Xxxxxxxxxx Xxxxxxxx xxx Xxxxxxxxxx Xxxxxx, Xxxxxx, Xxxx 00000
(hereinafter collectively referred to as "OU/Edison" or "Licensor"), and DRUG
DEVELOPMENT INVESTMENT CORP., a corporation organized and existing under the
laws of Texas, having a principal place of business at 000 Xxxxxxx Xxxx, Xxxx
Xxxx, Xxxxxxxxxxxx 00000, including all Affiliates, as herein defined
(hereinafter collectively referred to as "Licensee").
RECITALS:
WHEREAS, Licensor, through the research conducted by Xxxx Xxxxxxxx and
those supervised by him, has developed technology in the field of growth
hormones that, among other applications, may be effective in the control,
prevention and treatment of disease; and has filed for patent protection
concerning the technology; and
WHEREAS, Licensor desires to promote the development of the technology and
its use for the public benefit, and to this end is granting to Licensee
exclusive rights and licenses in the patents, patent applications, technical
information and know-how related to and constituting the technology, and
Licensee desires to accept such rights and licenses in accordance with the terms
set forth below.
NOW, THEREFORE, in consideration of the foregoing and the mutual agreements
contained herein, the parties agree as follows:
1. DEFINITIONS.
(A) "AFFILIATE" means, with respect to either party, any legal entity that
directly or indirectly controls, is controlled by, or is under common
1.
control with, such party. For purposes of this definition, "control" means the
power, whether or not normally exercised, to direct the management and affairs
of a legal entity, directly or indirectly, whether through the ownership of
voting securities, by agreement, custom or law. In the case of a corporation or
partnership, the direct or indirect ownership of fifty percent (50%) or more of
its outstanding voting equity shall in any case be deemed to confer control,
provided that the direct or indirect ownership of a lesser percentage of such
equity shall not necessarily preclude the existence of control where such
control is otherwise shown to exist, particularly with respect to a foreign
entity where legal limitations on the maximum foreign equity ownership may
apply.
(B) "DERIVATIVE PRODUCTS" means all products, including compounds, services
or methods of treatment, derived from the Licensed Technology.
(C) "DOLLARS" and "$" refer to the official currency of the United States
of America.
(D) The "EFFECTIVE DATE" of this Agreement, subject to Section 20(b), shall
be deemed to be January 18 , 1993.
(E) "FDA" means the U.S. Food and Drug Administration, and any successor
agency thereof.
(F) "IND" means an Investigational New Drug application submitted to the
FDA under the regulations set forth in 21 Code of Federal Regulations Part 312
or any successor regulations thereof, providing for studies of the use or
efficacy of the Licensed Technology and/or Derivative Products in the prevention
and/or treatment of disease in humans.
(G) "LICENSED TECHNOLOGY" means: (i) all growth hormone analogs (including
growth hormone agonists and antagonists), growth hormone receptor analogs and/or
other products or targets of intracellular growth hormone action (including
second messengers or other intracellular mediators of growth hormone
2.
action), and molecules of inorganic, organic or other structure with growth
hormone mimetic (and/or growth hormone antagonistic) effects; (ii) all
transgenic animals and cell lines that express such growth hormone analogs,
growth hormone receptor analogs and/or other products or targets of
intracellular growth hormone action; (iii) all methods of treating human
diseases utilizing such growth hormone analogs, growth hormone receptor analogs
and/or other products or targets of intracellular growth hormone action, that
have been discovered or developed at OU/Edison to date, or that are hereafter
discovered or developed at OU/Edison or in collaboration with OU/Edison (to the
extent of OU/Xxxxxx's rights in or with respect to such technology), in either
case (A) through research conducted by Xxxx Xxxxxxxx and those supervised by
him, or (B) in conjunction with or under the auspices of the Edison Animal
Biotechnology Center, or any facility controlled by the Edison Animal
Biotechnology Center during the term of the Sponsored Research Agreement,
including but not limited to the specific inventions by Xxxx X. Xxxxxxxx and
those supervised by him relating to growth hormone action; and (iv) all methods,
procedures and uses for assaying growth hormone or growth hormone analog
presence in fluids or other media, and/or growth hormone or growth hormone
mimetic or growth hormone antagonistic biologic action, including methods for
screening compounds for desired biologic activities and methods for the
diagnosis or treatment of disease. In the event growth hormone research is
conducted by an institution or facility that is not sponsored or controlled by
OU/Edison, but OU/Xxxxxx or Xxxx X. Xxxxxxxx (or those supervised by him in
research matters relating to growth hormone action) cooperates in the
performance of the research, or consults with respect to such research, and Ohio
University or OU/Xxxxxx acquires patent rights with respect to the discoveries
and inventions thereby developed, such rights shall be deemed a part of the
Licensed Technology. The Licensed Technology shall also be deemed to include the
3.
Derivative Products, the Patent Rights and the Production Technology, as herein
defined. The only exception to Licensed Technology defined in this section 1(g)
is a previous research contract (unamended) between OU/Edison and American
Cyanamid Company dated June 12, 1992 (the "American Cyanamid Contract").
(H) "LITIGATION COSTS" and "ARBITRATION COSTS" mean all expenses reasonably
and customarily incurred in litigation or arbitration proceedings, respectively,
including court costs, arbitration fees, attorney's fees, consulting and
testifying expert fees and customary copying, telephone, telefax, postage and
similar costs. A reference to Litigation Costs shall mean Arbitration Costs, and
vice versa, where appropriate to the context.
(I) "NET REVENUES" shall mean all revenues actually received by the Seller
(as herein defined) from the Sale (as herein defined) of the Derivative Products
in the marketplace, not including the following: (i) discounts allowed in
amounts customary in the trade; (ii) sales, VAT and use taxes, and tariffs and
custom duties imposed with reference to particular Sales; (iii) outbound
transportation charges prepaid or allowed; (iv) amounts allowed or credited on
returns; and (v) packaging and insurance charges on shipments or deliveries to
customers.
(J) "OPTION AGREEMENT" means that certain agreement between Ohio University
and Licensee of approximately even date granting Licensee option and first
refusal rights with respect to certain ancillary technologies related to the
Licensed Technology.
(K) "PATENT RIGHTS" means (i) those patent applications listed in Exhibit A
attached hereto and made a part hereof, and any other patent applications that
relate to or embody the Licensed Technology (collectively, the "Patent
Applications") and (ii) all letters patent (collectively, the "Licensed
Patents") issuing on any Patent Applications, whether foreign or domestic,
together with
4.
all registrations, amendments, divisions, continuations, continuations in part,
extensions and renewals, reexaminations, improvements, substitutions, additions,
confirmations and revalidations and reissues thereof.
(L) "PRODUCTION TECHNOLOGY" means the full range of technical information
and know-how, processes, procedures, devices, compositions, methods, formulae,
protocols, techniques, quality control standards, measurements, assays and
studies, software programs and underlying source codes, designs, drawings and
data now or hereafter acquired, controlled by, and/or available to Licensor
relating to the Licensed Technology and Derivative Products that is not
contained within the claims of the Patent Rights, but which is necessary at any
time for practicing the inventions covered by the Patent Rights, or non-patented
inventions covered by the Licensed Technology. Excluded from the definition of
Production Technology are the computer programs used in biomolecular modeling of
the growth hormone created by the Ohio University, College of Engineering. The
biomolecular modeling computer programs are subject to the terms of the
"Software Licensing Agreement" between University and Licensee of approximately
even date herewith.
(M) "REGULATORY APPROVAL" means, with respect to a given country, all
approvals from any Regulatory Authority necessary for Licensee to conduct its
business with respect to the Licensed Technology in such country.
(N) "REGULATORY AUTHORITY" means the governmental authority responsible for
making and/or enforcing applicable public laws and regulations, or granting
Regulatory Approval in a given jurisdiction.
(O) "SALE" means any sale, lease, license, sublicense, distribution,
transfer, assignment in whole or in part, exchange, or other disposition for
value by Licensee, Sublicensee or Licensee's Affiliates to a party other than
Licensor or Licensee, or their respective Affiliates, of any rights held or
5.
Derivative Products acquired by Licensee hereunder, and shall include without
limitation the use of such term as contemplated by 35 U.S.C. Section 154. The
terms "Sell," "Sold" and "Selling" shall have an analogous meaning to Sale.
"Seller" shall mean a person who Sells a Derivative Product.
(P) "SPONSORED RESEARCH AGREEMENT" means that certain agreement between the
parties by that title of approximately even date herewith.
2. LICENSE GRANT.
(A) Licensor hereby grants to Licensee (including its Affiliates) and
Licensee hereby accepts, upon the terms and conditions herein set forth, an
exclusive worldwide license (the "License") in and to the Licensed Technology,
including, without limitation, the exclusive right under the Licensed
Technology, to make, use, and Sell (directly or through independent
distributors) the Licensed Technology in accordance with this Agreement, and
also including, without limitation, the right to pursue further research,
discoveries and inventions, and construct or acquire any apparatus and
facilities useful in the development of the Licensed Technology. Licensee shall
have the right to transfer, in whole or in part, the rights granted in this
Agreement to any Affiliate as provided in Section 22 below. Subject to the
provisions of Section 17(g) below, Licensor shall not distribute to any third
party any part of the Licensed Technology without Licensee's prior written
consent.
(B) Licensor will not compete directly or indirectly with the commercial
exploitation by Licensee or any sublicensee of the Licensed Technology, or any
portion thereof, during the term of this Agreement, except that Licensor shall
have the unrestricted right to fully utilize and commercially exploit any
portion of the Licensed Technology in which Licensor may hereafter reacquire
rights pursuant to the terms of this Agreement. Licensor shall not assert any
Patent
6.
Rights against Licensee relating to the Licensed Technology prior to the lawful
termination of the rights granted under this Agreement.
(C) Licensor agrees that it will not intentionally divert research from the
Edison Animal Biotechnology Center in a manner which would operate to circumvent
its commitments under this Agreement.
(D) OU agrees that (i) it will not expand the scope in a manner that would
interfere with, the rights granted herein, or extend the term of the aforesaid
American Cyanamid Contract beyond June 15, 1994 if such extension would in any
manner inhibit or impair the performance of OU/Xxxxxx's responsibilities under
this Agreement or the Sponsored Research Agreement, (ii) it will segregate the
funding received on the American Cyanamid Contract so that no such funding is
expended on the activities contemplated under the Sponsored Research Agreement
or this Agreement, (iii) it will maintain separate records with respect to the
research conducted in accordance with the American Cyanamid Contract to assure
that such research is not commingled or confused with the research to be
conducted on behalf of Licensee under the Sponsored Research Agreement, (iv) it
will not assign research responsibilities under the Sponsored Research Agreement
to any individual who is conducting research under the American Cyanamid
Contract, and (v) it will not capitalize on any results obtained through
research activities under the American Cyanamid Contract in pursuing its
responsibilities under the Sponsored Research Agreement. OU/Xxxxxx represents
that it has not, and agrees that it will not, enter into any other contractual
commitments or undertake any research activities that would conflict with,
detract from, or give rise to any claim against the rights granted to Licensee
in this Agreement.
(E) Licensor hereby grants to Licensee the right to sublicense any rights
granted hereunder without additional consideration to Licensor, other than the
obligation to make all payments required under this Agreement. Licensee agrees
7.
that (i) any sublicense agreement shall be consistent with the terms hereof,
(ii) the provisions contained in Sections 8, 9 and 17 hereof shall expressly be
made binding on each sublicensee, (iii) except as may otherwise be agreed in
writing between Licensor and Licensee, Licensee shall remain primarily liable to
Licensor for the performance of the Licensee's obligations under this Agreement,
irrespective of any such sublicense, (iv) Licensee shall furnish a copy of each
sublicense to Licensor, and (v) each sublicense shall terminate as provided in
Section 16 below.
(F) In the event Licensee grants a sublicense or rights to any part of the
Technology to any third party, Licensee shall cause such transferee to execute a
document (a copy of which shall be furnished to Licensor) providing for the
payment to Licensor of any and all royalties due on units of Derivative Product
that may be sold by such transferee in the marketplace, and Licensee hereby
guaranties such payment to Licensor. No duplicate royalty payments shall be made
to Licensor, however, under any circumstances with respect to the sale of any
Derivative Product, irrespective of whether such Derivative Product is covered
by more than one Licensed Patent.
(G) Licensee shall have the right, at any time, and from time to time, to
surrender any portion(s) of the Licensed Technology to Licensor, and from such
date(s) the rights so surrendered shall no longer be deemed part of the Licensed
Technology covered by this Agreement, and in such event Licensee shall give
written notice to Licensor specifying the Licensed Technology so surrendered.
(H) In the event any representative of Licensee develops joint inventions
with Licensor or with Xxxx Xxxxxxxx, during Xxxxxxxx'x employment by Licensor,
Licensee shall require that such joint inventions and discoveries (or any patent
applications filed with respect thereto, and any patents issued thereon) be
assigned jointly to Licensee and Licensor; and Licensor's joint interest in such
8.
joint inventions shall be Licensed to Licensee hereunder; Licensee shall make
Royalty Payments on Net Revenues thereon, and pay other compensation that may
become due, in accordance with this Agreement and Exhibit B; however, Licensee
shall retain all other rights that it may have under statute and common law with
respect to the commercial exploitation of such joint inventions. This paragraph
(h) shall not apply to inventions and discoveries that are developed by Licensee
without Licensor's joint collaboration, however.
3. TECHNICAL AND SCIENTIFIC ASSISTANCE.
(A) Licensor shall disclose and furnish to Licensee as soon as reasonably
practicable after the Effective Date, in English language, or in readily
convertible computer software code, where applicable, and in American units (as
to measurements) all of the Licensed Technology, including any Licensed
Technology that may hereafter come into Licensor's possession during the term of
this license, including information concerning all applications in which the
Licensed Technology has been or may be successfully employed, and details
retained in any format, including electronic media, with a view to enabling
Licensee to fully exploit this license.
(B) Licensor shall assist Licensee by responding to questions concerning
the Licensed Technology. To this end, Licensor agrees, upon request by Licensee
and at Licensee's expense (in accordance with Section 3(c)), to send to any
facility designated by Licensee where Production Technology will be used,
qualified representatives of Licensor selected by mutual agreement of Licensor
and Licensee, at reasonable intervals and for reasonable periods and in a manner
not calculated to disrupt their normal responsibilities, to assist Licensee in
utilizing the Production Technology, and to consult with Licensee with respect
to the development and manufacture of Derivative Products.
9.
(C) Subject to Licensee's right to approve expenses exceeding $500 in
advance of any such trip, Licensee agrees to pay all reasonable documented
travel expenses and lodging costs of Licensor's personnel incurred under
paragraph (b) above, upon receipt of invoice within thirty (30) days after such
expenses have been incurred.
4. PATENT FILING, MAINTENANCE AND EXTENSION.
(A) During the term of this Agreement, subject to feasibility
determinations made in consultation with expert patent counsel, Licensee shall,
with Licensor's cooperation, (i) prosecute Patent Applications at Licensee's
expense, (ii) keep Licensor informed of the status of such applications, and
(iii) seek the broadest degree of protection in the patent claims that is
consistent with sound patent law practice. In the event Licensor believes that
patent protection should be sought with respect to specific inventions, and
Licensee has not done so, Licensor shall identify the inventions in a written
notice to Licensee requesting Licensee to proceed with the filing and
prosecution of a Patent Application (the "Patent Request").
(B) In the event Licensee receives a Patent Request during the term of
this Agreement and decides, for any reason, not to prosecute the Patent
Application, it shall confer with Licensor about such decision, and shall
communicate its reasons for not pursuing the patent. It shall be deemed a Valid
Reason (herein so called) if Licensee states reasonable and probable grounds for
believing that publication of the patent claims would be detrimental to the
mutual objectives of the parties under this Agreement for reasons of
confidentiality or in order to avoid infringing the patent rights of any third
party. If Licensee has not stated a Valid Reason for failing to pursue the
patent, and has not agreed within sixty (60) days after receipt of the Patent
Request, to file
10.
the Patent Application, Licensor shall have the right, but not the obligation,
at its expense, to prosecute such Patent Application. If Licensor decides to
prosecute a Patent Application that Licensee has elected not to prosecute, any
patent that issues based on such application shall be the sole property of
Licensor and will not be part of the Licensed Technology under this Agreement;
provided, however, that Licensor shall promptly give Licensee notice of the
issuance of such patent, and copies of the relevant patent and underlying
materials, and Licensee shall thereafter have a period of sixty (60) days in
which to elect to obtain an exclusive license to such patent from Licensor by
paying Licensor an amount equal to the costs incurred by Licensor in obtaining
the patent. Upon affirmative exercise of this election and payment to Licensor,
the subject patent shall thereafter constitute part of the Licensed Technology
and be subject to this Agreement.
(C) During the term of this Agreement, Licensee shall take the steps and
pay all fees reasonably necessary to maintain the Licensed Patents for the full
term thereof; provided that if Licensee decides that it is not cost-effective or
reasonable to maintain a particular Licensed Patent, Licensee shall so inform
Licensor in writing as soon as practicable, and Licensee shall also advise
Licensor in writing whether the technology covered by the patent is presently
embodied in any Derivative Product, and if so, which ones. Licensor shall then
have the right, but not the obligation, to take such steps at its own expense.
If (i) Licensee elects to abandon Licensed Patent(s) for any reason other than
those listed above in Section 4(c) or avoidance of infringement of rights of a
third party, (ii) royalties have not been paid to Licensor with respect to a
Derivative Product embodying the Technology covered by the claims in such
Licensed Patent(s), and (iii) Licensor elects to undertake protection of such
11.
Licensed Patent(s), such Licensed Patent(s) will from that point on no longer be
considered Licensed Technology under this Agreement.
(D) Licensee shall have the right to file on behalf of and as agent for
Licensor, all applications and to take all actions necessary (i) to obtain the
benefits under the Drug Price Competition and Patent Term Restoration Act of
1984 and any amendments thereof and (ii) to extend the terms of the Licensed
Patents to the extent permitted by any other law through, among other measures,
applications for patent extension certificates, provided that Licensor shall
join in such applications if requested to do so by Licensee.
(E) All Patent Applications shall be prosecuted in the name of the
inventor(s), subject to Ohio law and OU/Edison policies, and Licensor shall
cause the Patent Applications and any Licensed Patents which may be issued
thereon to be assigned to Licensee hereunder, unless otherwise agreed by the
parties. In the event this Agreement is terminated, the rights of the parties in
pending Patent Applications and Licensed Patents shall be controlled by Section
16 below.
5. PATENT INFRINGEMENT ACTION BY A THIRD PARTY.
(A) In the event any third party asserts a claim of patent infringement
with respect to the Licensed Technology against Licensor, Licensee, or any
person acquiring or holding rights in the Licensed Technology through them, the
party who first learns of such claim shall promptly notify the other party of
the claim. Licensee shall have the right and obligation to defend against such
claim, in its own name and/or in the name of Licensor, if necessary to such
defense. The parties (i) shall cooperate in taking all appropriate and
reasonably necessary actions to diligently maintain the defense of such claim,
including litigation and the maintenance of any bona fide appeals therefrom, and
having its representatives and employees testify and make available all relevant
12.
nonprivileged materials; (ii) subject to any right of indemnity under Section 19
below, shall initially bear their own respective Litigation Costs incurred in
connection with such defense; provided that during the pendency of the dispute,
subject to the provisions of Section 8(f) below, Licensee may [*] due Licensor
under this Agreement and apply same toward reimbursement of Licensee's expenses
(including all Litigation Costs) in connection with the action, until such time
as the litigation is finally resolved, whether through settlement, consent
judgment, or final judgment from which no further appeal may be taken. In the
event the Royalty Payments have been reduced pursuant to any provision contained
in this Agreement, the amount withheld shall be calculated based upon the
reduced Royalty Payment. In the event that the amount of Royalty Payments
withheld exceeds the Licensee's expenses (including Litigation Costs), then
Licensee shall, upon final resolution of the subject litigation, pay Licensor
within sixty (60) days of such final resolution, the balance of any such Royalty
Payments withheld hereunder.
(B) If Licensee does not diligently prosecute such defense, or elects not
to do so, then subject to Licensor's obligations under its indemnity in Section
19 below, Licensor shall have the right, but not the obligation, to assume such
defense at its own expense, in which event Licensee shall cooperate by having
its employees and representatives testify and make available all nonprivileged
materials.
(C) If Licensee is required, by a settlement entered into in good faith
after consultation with Licensor, or by a final court order from which no appeal
can be taken, to pay any sum of money (i) as damages, or (ii) as a compulsory
royalty to obtain a license under any patent (within the field of the Licensed
Technology) not licensed hereunder, in order to exploit the License, and the
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
13.
infringement of such patent cannot reasonably be avoided by Licensee, the
compensation required to be paid to Licensor under the terms of Exhibit B to
this Agreement shall be reduced by the amount so payable by Licensee to the
third party. To the extent not recouped by Licensee pursuant to the foregoing
provisions, Licensor shall reimburse Licensee for any expenses, liabilities and
damages incurred in connection with the defense, settlement, or payment of such
claim if it is determined that (i) any representations made by Licensor under
Section 10 are invalid, and as a result thereof the claim was not reasonably
defensible in whole or in part, or (ii) a material claim adverse to the Patent
Rights has been asserted and such claim results in a judgment against Licensee
(or its Affiliates or sublicensees), or, in the good faith judgment of
independent expert patent counsel, would result in such adverse judgment if not
amicably resolved. Such reimbursement shall be paid to Licensee, however, only
out of compensation thereafter due Licensor under Exhibit B to this Agreement
unless such right to reimbursement results from a breach of Licensor's
affirmative representations or express duties contained herein, or pursuant to
Licensor's indemnity under Section 19 below.
(D) The parties shall confer in good faith in an attempt to reach agreement
before accepting any settlement or entering into any consent judgment in any
proceeding maintained under this Section. Neither party shall settle any claim
concerning the Licensed Technology without the prior written consent of the
other party, which shall not be unreasonably withheld.
6. PATENT INFRINGEMENT ACTION AGAINST A THIRD PARTY.
(A) If any third person shall, in the reasonable opinion of either party,
infringe any of the Licensed Patents, such party shall promptly notify the other
party of the facts pertaining to such infringement. The parties shall initially
14.
endeavor to amicably resolve the dispute with the third party. Licensee shall
have the sole right in accordance with the terms of this Agreement to sublicense
any alleged infringer for the future use of rights under the Licensed Patents,
in which event any fees so received shall be applied first to defray pro rata
any Litigation Costs incurred by the parties as a result of the infringement and
sublicense so granted; and any balance of such fees shall be treated as
comprising a part of Net Revenues hereunder.
(B) In the event efforts to amicably resolve the dispute are unavailing,
Licensee initially shall have the right to prosecute a legal action against the
infringer, in its own name or in the name of Licensor (or its scientists) if
necessary, together with the right to enforce and collect any judgment thereon.
If Licensee exercises such right, Licensor shall cooperate at its expense in the
prosecution of such action, including consenting to being joined in such action,
if necessary, and providing pertinent nonprivileged testimony and materials.
Licensee initially shall bear its own expenses associated with management of the
action; provided that Licensee may [*] thereafter due Licensor under this
Agreement, subject to provisions of Section 8(f) below, and apply same toward
reimbursement of Licensee's expenses (including Litigation Costs) in connection
with the action, until such time as the litigation is finally resolved, whether
through settlement, consent judgment, or final judgment from which no further
appeal may be taken. In the event the Royalty Payments have been reduced
pursuant to any provision contained in this Agreement, the amount withheld shall
be calculated based upon the reduced Royalty Payment. In the event that the
amount of Royalty Payments withheld exceeds the Licensee's expenses (including
Litigation Costs), then Licensee shall, upon final resolution of the subject
litigation, pay
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
15.
Licensor within sixty (60) days of such final resolution, the balance of any
such Royalty Payments withheld hereunder.
(C) In the event Licensee does not diligently exercise its right to
maintain an action against an infringer hereunder, Licensor shall have the
right, but not the obligation, to initiate and manage such action. Licensee
shall cooperate reasonably in the maintenance of such action by furnishing
pertinent nonprivileged evidence, and Licensor shall bear the Litigation Costs
associated with the management of such action.
(D) Any monetary recovery in connection with such infringement action
shall be applied (i) first, to reimburse Licensee (or Licensor, if it has
maintained the action) for its unreimbursed out-of-pocket expenses (including
Litigation Costs) in prosecuting such action; (ii) next, to the unreimbursed
out-of-pocket expenses of the other party incurred in connection with such
action; (iii) next, to any outstanding reimbursement or indemnity obligations
then due Licensee; and (iv) then, in reimbursement to Licensor of any royalty
obligations past due or withheld pursuant to this Section 6. The balance, if
any, shall be treated as comprising a part of Net Revenues hereunder.
(E) During the pendency of any such infringement and ensuing action, if
the quantity of the dosage units of the infringing products sold by the
infringing competitors during a payment period is at least [*] of the sum of the
dosage units of (i) the infringed Derivative Products sold by Licensee in the
same country or countries plus (ii) the dosage units of the infringing products
sold by the infringing competitors in such payment period, then any Royalty
Payments arising under this Agreement on account of the infringed Derivative
Products and attributable to such payment period shall be reduced
(retroactively, if necessary) by the same percentage, subject to the provisions
of Section 8(f) below.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
16.
(F) The parties shall confer in good faith in an attempt to reach agreement
before accepting any settlement or entering into any consent judgment in any
proceeding maintained under this Section. Neither party shall settle any claim
concerning the Licensed Technology without the prior written consent of the
other party, which shall not be unreasonably withheld.
7. COMPULSORY LICENSEES.
If a third party obtains from a Regulatory Authority, a compulsory
license to practice any rights granted under a Licensed Patent in any country or
countries, Licensor (or Licensee, as the case may be) shall give prompt notice
thereof to the other party. If the quantity of the dosage units of the
Derivative Products sold by the compulsory licensee during a payment period is
at least [*] of the sum of the dosage units of (i) the Derivative Products sold
by Licensee in the same country or countries plus (ii) the dosage units of the
Derivative Products sold by the compulsory licensee in such payment period, then
the royalty rate applicable hereunder to Licensee's Net Revenues on account of
the Sale of Derivative Products in the affected country or countries and
attributable to such payment period shall be reduced to such lesser royalty
rate, if any, as may be applicable under the compulsory license to the
compulsory licensee's Sales of the Derivative Products, subject to the
provisions of Section 8(f) below.
8. PAYMENT.
(A) In consideration of the rights granted herein, Xxxxxxxx agrees to make
the Royalty Payments (herein so called) required on Exhibit B attached hereto to
Licensor. Amounts payable under this Agreement shall be paid in U.S. dollars to
Licensor or in such other currencies as the parties may agree upon in
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
17.
writing. Such Royalty Payments shall be subject to applicable law and
regulations existing at the place of remittance. Net Revenues not denominated in
Dollars shall first be determined in the currency in which such Derivative
Products were sold and shall then be converted into the equivalent number of
Dollars at (i) the official closing institutional buy rate, two days prior to
the date of payment hereunder, established by the official central bank or
exchange control authorities in each such country; or (ii) if no such official
rate is available or if conversion pursuant to such official rate cannot be
effected by Licensee, then at such closing rate, two days prior to the date of
payment hereunder, established by Chase Manhattan Bank, N.A. in New York City.
In the event the compensation received by Licensee, on which Royalty Payments
are otherwise due, is not a cash equivalent, the fair market value of such
compensation in kind will be the basis on which the cash Royalty Payments are
calculated.
(B) All Royalty Payments shall be made to Licensor at its Technology
Transfer Office address furnished for notices in accordance with Section 25
below, and as to funds which cannot be converted from foreign currencies, or
cannot be exported from foreign jurisdictions, then in the manner that Licensor
reasonably requests. Licensor shall have the right, by at least fifteen (15)
days notice to Licensee, to designate an account at a depository bank in the
United States for the wiring of any Royalty Payment that then may be due.
(C) If at any time and for so long as any applicable governmental or fiscal
regulations or policies restrict Licensor's right to receive the fees payable
hereunder in U.S. funds in the United States, Licensee shall be deemed to have
fulfilled its obligations to make the Royalty Payments due hereunder, if it pays
the sums due into a foreign bank account designated by Licensor, or into
18.
a foreign branch of the Chase Manhattan Bank in the name of Licensor, for wiring
to the account of Licensor in the U.S., with notice to Licensor of such deposit.
(D) The royalties shall be payable during the term of this Agreement (the
"Term") for each Royalty Payment Period (as hereinafter defined) during which
Net Revenues are collected with respect to the Sale of Derivative Products in
the marketplace, subject to the provisions of Sections 5, 6 and 7 above, and
8(f) below; provided that (i) as to Derivative Products that have never been the
subject of patent protection the obligation to pay royalties shall terminate [*]
years after the first commercial sale of such Derivative Product, and (ii) for
[*] years after the expiration of any Licensed Patent covering a Derivative
Product, the royalties payable to Licensor with respect to such Derivative
Product shall be [*], determined on a country by country basis, as [*], and no
Royalty Payments shall be required with respect to such Derivative Product
thereafter.
(E) No royalty shall accrue on any Sale of Derivative Products between
Licensee and its Affiliates or either of them and their respective sublicensees,
except as expressly provided in this Agreement.
(F) In the event Licensee is entitled to withhold against Royalty Payments
pursuant to Sections 5(a), 6(b) or (e) or 7, Licensor shall not be required to
refund any Royalty Payment or any Research/Royalty Payment previously made to
Licensor, and Licensee shall not seek to enforce any such refund.
(G) If it can reasonably be concluded that a sublicensee has acquired
rights to a Derivative Product without a bona fide intent to market same, but
for the purpose of eliminating competition with another product in the
marketplace,
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
19.
and no reasonable effort can be shown to deliver the Derivative Product into the
stream of commerce, and no sale of a material quantity of the Derivative Product
in the marketplace occurs within a period of [*] after the transfer to the
sublicensee, and there are no extenuating regulatory circumstances for such
delay, Licensee shall pay Licensor a royalty on the amount of the fee received
from the sublicensee for the acquisition of the rights to such Derivative
Product, which fee shall be treated as Net Revenues. If a Derivative Product is
thereafter Sold in the marketplace pursuant to the sublicense, however, Licensee
shall be entitled to recoup from the royalties otherwise due Licensor from such
Sales, the amount of the Royalty Payment already paid to Licensor on the fee for
the sublicense transaction, and after such recoupment is complete, Licensor
shall be entitled to receive the stream of Royalty Payments due on Net Revenues
from the Derivative Products.
(H) In the event a sublicensee, having acquired the entire Licensed
Technology, fails to commercially exploit the Licensed Technology within [*]
after the transfer or eight years after the date hereof, whichever is later, and
there are no extenuating regulatory circumstances for such delay, then the
sublicensee will be required [*] to Licensor, for each year that the Licensed
Technology is not commercially exploited from the date of the transfer through
the year in which (i) the term of the last Licensed Patent to expire,
terminates, or (ii) the license to the Licensed Technology is surrendered to
Licensor by the sublicensee, whichever is sooner.
(I) If, for remuneration, Licensee enters into a sublicense specifically
granting rights to an independent third party for the use of an assay or other
testing or diagnostic procedure or instrument constituting a part of the
Licensed
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
20.
Technology, which has financial value separate and apart from the creation of a
Derivative Product, Licensor shall be entitled to receive a Royalty Payment
based on such remuneration.
9. REPORTING AND RECORD KEEPING.
(A) Licensee will render to Licensor, no later than thirty (30) days
following January 1, April 1, July 1 and October 1 of each year, respectively
(the "Royalty Payment Periods"), a written statement summarizing Sales activity
conducted pursuant to this Agreement. The statement will be certified as to its
correctness by an officer of Licensee, and will provide such information
concerning the nature of the business conducted pursuant to this Agreement by
Licensee during the preceding three (3) month period as shall be pertinent to an
accounting hereunder, including at least the following:
(I) number and description of units of Derivative Products
sold;
(II) total Net Revenues, itemizing all deductions;
(III) accounting for all sublicenses granted, including names
and addresses of such sublicensees;
(IV) total Royalty Payments due; and
(V) any special reporting required pursuant to Section 4(c)
above. Each such statement shall be accompanied by the Royalty Payment due to
Licensor as of the last day of that Royalty Payment Period.
(B) Licensee shall keep full and accurate books and records setting forth
all Sales, the computation of Net Revenue (including the licensing fees paid by
sublicensees) and all information that is required to be set forth in the
royalty statements hereunder. Licensee shall permit an independent certified
public accountant selected by Licensor and acceptable to Licensee, to examine
such books and records, upon reasonable notice and during normal working hours,
but not
21.
later than two (2) years following the payment in question, for the purpose of
verifying the reports, accountings and payments hereunder. The cost of such
examinations shall be borne by Licensor unless a material error resulting in an
underpayment of royalties that exceeds [*] of the royalties due for the period
examined is discovered in the records or in the royalty statements based
thereon, in which event the cost of the examination in which the errors were
discovered will be borne by Licensee. In the event errors are discovered in the
accounting, appropriate adjustments shall be made in the Royalty Payments due.
The independent accountant shall not disclose to Licensor any cost data of
Licensee, but Licensee shall permit Licensor's accountant to make such excerpts
and copies of the financial records as may be necessary to perform the audit.
(C) Licensee shall furnish Licensor with status reports summarizing the
status of its development of Licensed Technology and Derivative Products, on
March 1 of each year. Licensee shall inform Licensor of each Derivative Product
that enters Phase I clinical pharmacology testing conducted under an IND filed
with the FDA or with its counterpart in any foreign country, and of each
clinical proof of concept demonstrated in a human clinical Phase II efficacy and
safety study.
10. LICENSOR'S REPRESENTATIONS AND WARRANTIES.
Licensor represents and warrants as follows:
(A) Licensor is the owner of all right, title and interest in and to the
Licensed Technology, has the right to grant the rights and Licenses herein
conferred upon Licensee, and no interest in the Licensed Technology has been
transferred to any third party by Licensor.
(B) Licensor has disclosed to Licensee all material information relating to
the Patent Applications, and has authorized Licensor's patent counsel to
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
22.
discuss any issues relating to the Patent Rights. Licensor represents that the
pending Patent Applications are accurate, and to the best of Licensor's
knowledge have merit. Licensor is unaware of any potential infringement of the
rights of any third person by the Patent Applications, or any Licensed Patents
that may be issued with respect thereto.
(C) Copies of the pages from the laboratory notebooks of Xx. Xxxxxxxx and
those supervised by him have been disclosed to the Licensee describing the
invention covered by the fourth Patent Application described on EXHIBIT A
attached hereto, and Licensor has confirmed that to the best of Licensor's
informed knowledge and belief, after consultation with expert patent counsel,
such invention was reduced to practice by Xx. Xxx X. Xxxx as early as Fall of
1991.
(D) Licensor has disclosed to Licensee all inventors of the Licensed
Technology who have performed research at Licensor's facilities, or in concert
with Licensor, and it has obtained and recorded assignments from each such
inventor assigning to Licensor all of the rights in inventions, discoveries and
Patent Applications comprising any portion of the Licensed Technology.
(E) Licensor has the authority and capability to execute and perform this
Agreement, and such execution and performance will not violate any restriction
contained in any law, regulation, policy of Ohio University, or agreement with
any third person.
11. LICENSEE'S REPRESENTATIONS AND WARRANTIES.
Licensee represents and warrants as follows:
(A) Licensee has the authority and capability to execute and perform this
Agreement, and such execution and performance will not violate any restriction
23.
contained in any law or regulation, or in any agreement between Licensee and any
third person.
(B) Licensee has share capital of not less than $100,000 and has employed
a Chief Executive Officer with expertise and managerial experience in the
pharmaceutical industry to direct the activities required under this Agreement.
12. LICENSEE'S DUTIES.
(A) Licensee shall use diligent efforts to commercially exploit the
Licensed Technology through the development of marketable Derivative Products
and shall undertake diligent efforts to Sell any commercially viable Derivative
Products that do not (i) present an unreasonable risk of injury to life or
health or (ii) violate the provisions of applicable laws and regulations of any
Regulatory Authority. Reasonable evidence provided by Licensee that it has an
ongoing and active research, development, manufacturing, marketing, or licensing
program directed toward Sale of Derivative Products shall be deemed satisfactory
proof of diligent efforts to commercially exploit the Licensed Technology and to
Sell the Derivative Products.
(B) Licensee agrees to pay all costs hereafter incurred in applying for
necessary Regulatory Approvals in the clinical trial process with respect to
Derivative Products constituting a part of the Licensed Technology. At the
request of Licensee, Xxxxxxxx agrees to assist and cooperate reasonably with
Licensee in the preparation and processing of each IND and each application for
Regulatory Approval.
(C) Unless extended by mutual written agreement, Licensee shall [*] (i)
pursue research, development and experimentation of Derivative Products, and
(ii) place a Derivative Product in clinical trials; and assuming Licensee does
so in good faith, it shall be deemed
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
24.
to have complied with its responsibility to exploit commercially the Licensed
Technology.
(D) In the event Licensee fails to perform its duties pursuant to this
Section 12, this Agreement shall terminate in accordance with Section 16.
13. MANUFACTURING FACILITY.
Licensee agrees [*] as may be mutually agreed upon by Licensee and
Licensor.
14. INSURANCE.
(A) Subject to applicable law, each party shall purchase and maintain such
insurance as may, in its discretion, be necessary and appropriate to protect
against risks of loss, damage to property, and injury to person in connection
with the performance of this Agreement.
(B) Each party shall at all times comply with the applicable requirements
of any governmental authority with respect to the maintenance of workers
compensation insurance, or a legally allowable alternative form of employees'
liability insurance, covering all employees engaged in the performance of
activities under this Agreement.
15. PATENT MARKING.
All Derivative Products (or their containers) shipped to or Sold in the
United States or in foreign countries shall be marked in such manner as to
conform with the patent laws and practice of the country of manufacture or Sale,
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
25.
including as appropriate, the patent number or the phrase, "patent pending". The
particulars of such marking shall be determined in Licensee's discretion.
16. TERM AND TERMINATION.
(A) The primary term of this Agreement shall be eight (8) years (the
"Primary Term"), unless extended by mutual written agreement.
(B) Upon the expiration of the Primary Term, provided Licensee is not then
in Default (as defined below) of its obligations under this Agreement, this
License shall continue as to all of the Licensed Technology discovered or
developed prior to the expiration of the Primary Term (excluding any portions of
the Licensed Technology that have reverted to Licensor under other provisions of
this Agreement). In the absence of other written agreement between the parties,
compounds, transgenic animals, and methods of treatment discovered by Licensor
after the Primary Term of this Agreement or after the Licensee's termination of
the Sponsored Research Agreement, whichever is sooner, will become the property
of Licensor.
(C) Licensor shall make full written disclosure to Licensee of all
inventions, discoveries and developments coming within the scope of the Licensed
Technology as of the expiration of the Primary Term. In the event that
inventions within the scope of the Licensed Technology have been discovered as
of the expiration of the Primary Term, but such inventions are still inchoate,
and Licensee determines within a period of two years thereafter that such
inventions are commercially viable, Licensee may declare by written notice to
Licensor that it elects to have such inventions remain part of the Licensed
Technology in which Licensee retains rights, subject to the terms of this
Agreement.
26.
(D) The term "Default" shall, with respect to either party, mean any of
the following events occurring during the Term:
(I) Any material breach of this Agreement or the Sponsored Research
Agreement consisting of the failure to make a payment required hereunder, which
breach remains uncured after sixty (60) days notice specifying the amount then
due;
(II) Any material non-financial breach of this Agreement or the
Sponsored Research Agreement, which breach remains uncured after ninety (90)
days notice specifying the nature of the breach; or
(III) The failure of a party to continue its business activities.
(E) In the event of a Default by Licensee, Licensor may at its election
(without prejudice to any other legal or equitable remedies that Licensor may
have), exercisable upon notice to Licensee, declare the License immediately
terminated, in which event Licensee shall forfeit entirely all rights and
interest in and to the Licensed Technology (including, without limitation, all
Patent Rights), and this Agreement shall terminate.
(F) In the event of a Default by Licensor, or in the event Licensee has
grounds for termination of this Agreement pursuant to paragraphs (g), (h) or (i)
below, Licensee may at its election (without prejudice to any other legal or
equitable remedies that Licensee may have), exercisable upon notice to Licensor,
either (i) terminate this Agreement, or (ii) continue to exploit commercially
the License, but thereafter the Licensee's obligations under this Agreement
shall be limited solely to those Royalty Payment obligations arising under this
Agreement as set forth in clause (c) of Exhibit B attached, and Licensee shall
continue to make periodic Royalty Period Payment reports in compliance with
Section 9.
27.
(G) Licensee shall have the right to terminate this Agreement in the event
that the Sponsored Research Agreement is terminated in accordance with its terms
by Licensee.
(H) Licensee shall have the right to terminate this Agreement at any time
upon (i) six (6) months notice to Licensor and (ii) payment of all amounts due
through the effective date of such termination.
(I) Licensee shall have the right to terminate this Agreement if any
Patent Application listed on Exhibit A (i) is determined to be invalid, (ii) a
final decision is made by the Patent and Trademark Office to reject the Patent
Application(s) despite Licensee's diligent effort to prosecute same, or (iii) a
material claim adverse to such Patent Application(s), or any Licensed Patent
issued with respect thereto, is filed against Licensee, and in the good faith
judgment of independent expert patent counsel such claim has a substantial
deleterious impact on the value of the Licensed Technology or a significant
likelihood of resulting in an adverse judicial determination as to the validity
of the Licensed Patent, and a judgment against Licensee with respect thereto.
(J) Upon termination of this Agreement for Default of Licensee,
notwithstanding any other language contained in this Agreement, any and all
sublicenses granted by Licensee prior to such termination shall automatically be
assigned to Licensor, shall continue in effect in accordance with their terms,
and shall thereafter (during the respective terms of such sublicenses) be
subject in all respects to the provisions of this Agreement, in addition to any
provisions contained in such sublicenses.
(K) Licensee and any sublicensee may, after the effective date of any
termination of this Agreement, complete and Sell all Derivative Products on hand
or in the process of manufacture at the time of such termination; provided that
Licensee shall make the Royalty Payments to Licensor required under this
28.
Agreement in accordance with Exhibit B, clause (c), and shall submit all royalty
reports required hereunder with respect to such Sales.
(L) Upon termination of this Agreement due to Default on the part of
Licensee, except (i) pursuant to paragraphs (f), (j) and (k) above, (ii) as
otherwise necessary to comply with the documentation requirements of any
Regulatory Authority, or (iii) as otherwise may be necessary to exploit or
enforce any rights lawfully retained by Licensee under this Agreement upon
termination, all Licensed Technology, and all materials related thereto,
including copies, excerpts, abstracts or summaries thereof, in whatever form or
media stored, shall be returned to Licensor upon request.
(M) In the event of termination, (i) all rights and obligations of the
parties which are expressly required, or by clear implication contemplated, to
survive termination shall survive such termination, including without limitation
all rights and obligations set forth in Sections 16, 17 and 19 hereof; and (ii)
all rights to receive payment of any financial obligations which have vested
prior to termination shall remain enforceable.
(N) In the event Licensee exercises its right to terminate this Agreement,
and Licensor thereupon elects to continue in effect any existing sublicense
agreements, Licensee shall have no further obligation regarding or under such
sublicense agreements, including but not limited to those obligations set forth
in Sections 2(f) and 8(h) above.
17. CONFIDENTIAL INFORMATION.
(A) Subject to the exceptions contained in paragraph (c) below, Licensor
and Licensee shall maintain in strict confidence all Licensed Technology,
including without limitation the Production Technology, which is disclosed by
one party to another, and any additional information which has been identified
as
29.
confidential, whether or not so labeled (the "Confidential Information"); and
neither party shall use or disclose the Confidential Information except as
contemplated by this Agreement.
(B) For purposes of paragraph (a), the public availability of certain
information related to the Licensed Technology shall not forfeit the
confidential nature of other Confidential Information, and the disclosure of
specific principles or information shall not justify disclosure of general
principles or information that remain confidential, and vice versa.
(C) Confidential information shall not include information:
(I) already known to the recipient, at the time of disclosure
hereunder, as evidenced by adequate written documentation;
(II) publicly known in the form available hereunder prior to the
Effective Date, or which thereafter becomes publicly known in that form, other
than through acts or omissions attributable to the recipient or its employees,
agents or Affiliates;
(III) disclosed to the recipient by a third party having a lawful
right to do so;
(IV) that is authorized in writing to be publicly disclosed, by the
party who supplied such information; or
(V) that is embodied in an issued patent.
(D) Licensor and Licensee may disclose Confidential Information on a "need
to know" basis, as follows: (i) to their respective employees and agents
performing research concerning the Licensed Technology, (ii) to Licensee's
Affiliates, distributors, sublicensees, contractors, and subcontractors, (iii)
by Licensee to potential lenders and other reliable sources of financing
necessary to perform this Agreement, (iv) by Licensee to potential candidates
for membership on Licensee's board of directors, (v) by Licensee to governmental
agencies and institutional review boards to obtain regulatory approval for
Derivative Products or clinical research studies, (vi) by Licensee to
investigators performing clinical trials, and to (vii) governmental units to
obtain
30.
funding for research; provided that all such persons shall be instructed as to
their duties of confidentiality in compliance with this Section 17, and shall be
required to agree to preserve such confidentiality.
(E) Each party agrees to store all material embodying Confidential
Information in a secure area where access is restricted and to make duplicates
of the Confidential Information only to the extent reasonably necessary to
perform this Agreement.
(F) Except as required by law or regulation, expressly allowed herein, or
otherwise agreed in writing, no press release or any other written statement
intended for use in the public media that discloses Confidential Information
pertaining to the Licensed Technology shall be made by either party. Licensor
and Licensee shall have the right to issue press releases (and Licensee may
distribute private placement memoranda and securities prospectuses) accurately
describing in general terms, (i) the execution of this Agreement and (ii) the
scope of their respective responsibilities and the nature of their objectives
under this Agreement, but shall make no representations concerning the Licensed
Technology or the Derivative Products, and shall not compromise any duty of
confidentiality concerning the Licensed Technology. However, the specific terms
of this Agreement shall be disclosed solely (i) to those persons who need to
know its contents, in order to facilitate performance of this Agreement by the
parties themselves, or (ii) as may be required by law, regulation or judicial
order. Licensor shall not issue any press release or public statement concerning
the Licensed Technology (i) that identifies Licensee without the latter's prior
written consent, which shall not be unreasonably withheld, or (ii) in violation
of the obligations of confidentiality imposed by this Section 17.
31.
(G) Licensor shall have the right to publish research and scientific data
only in strict accordance with Article VI of the Sponsored Research Agreement.
(H) In the event disclosure of this Agreement or of other Confidential
Information is required by law, regulation or judicial order, the parties shall
take all reasonable measures available to limit the scope and purposes of
disclosure and to protect the confidentiality of such Confidential Information
upon such disclosure.
(I) Both Licensee and Licensor shall take precautions that no Licensed
Technology, including without limitation Production Technology, and no
Derivative Product, will be disclosed or shipped, directly or indirectly, to any
person or entity, governmental or otherwise, of any foreign nation, if doing so
would violate the laws or regulations of the United States or knowingly violate
the laws of any foreign government.
(J) The obligations imposed by this Section 17 shall survive the
termination of this Agreement for a period of [*].
18. NEW DEVELOPMENTS.
(A) Licensor and Licensee agree to keep each other regularly and fully
informed about new applications and other developments relating to the
manufacture, use and Sale of the Licensed Technology, including Production
Technology. If during the Primary Term of this Agreement, Licensor and/or any of
its employees, agents or subcontractors shall make an invention, discovery,
development or improvement related to the Licensed Technology (collectively, a
"Development"), Licensor shall furnish to Licensee, without additional charge,
technical data and information relating to such Development. In addition, if
Licensee secures patent protection on any such Development, these patents shall
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THE COMMISSION. CONDFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
32.
be included in the definition of Licensed Patents as such term is defined in
Section 1 above.
(B) Subject to the right of Licensee to receive assignments of Patent
Applications and Licensed Patents as provided in Section 4(e) above, Licensor
shall obtain the assignment to Licensor from its employees, agents,
subcontractors, and other persons under its control who claim an interest in
each Development of all such interest in such Development and any patents issued
with respect thereto, in accordance with Ohio law and the Ohio University Policy
on Intellectual Property Ownership and Disposition, and Employee Involvement in
Research Commercialization Endeavors (Procedure no.17.001, effective November 8,
1992). Copies of such assignments shall be promptly furnished to Licensee.
19. INDEMNIFICATION.
(A) Licensee agrees to indemnify, hold harmless and defend Licensor from
all claims, liability, loss, damage and judgments (collectively, the "Claims")
asserted against or incurred by Licensor (including Litigation and Arbitration
Costs), caused by or arising out of (i) Licensee's use, research, or transfer of
the Licensed Technology, (ii) Licensee's performance of this Agreement, (iii)
work product derived from any independent research conducted by Licensee with
respect to the Licensed Technology that infringes any patent, trademark,
copyright, or any other proprietary right of any third party, (iv) Licensee's
manufacture or Sale of the Derivative Products in accordance with this
Agreement; (v) any actions of Licensee in performance of this Agreement that
violate any law or regulation of any governmental authority, or (vi) any actions
of Licensee in performance of this Agreement that violate any restriction or
agreement applicable to Licensee; provided, however, that (x) such indemnity is
subordinate to any insurance coverage applicable to the Claims and applies only
to the extent
33.
that the Claims exceed the limits of such insurance coverage, and (y) any such
Claims resulting from the factors identified in Subsection (A), (B ) or (C)
below are excluded from this indemnity:
(A) the failure of Licensor to comply with any applicable FDA or
other governmental laws, regulations or requirements;
(B) Licensor's breach of any covenant or representation contained in
this Agreement; or
(C) the negligence or willful malfeasance of Licensor.
(B) Licensor agrees, to the extent permitted by law, to indemnify, hold
harmless and defend Licensee from all claims, liability, loss, damage and
judgments (collectively, the "Claims") asserted against or incurred by Licensee
(including Litigation and Arbitration Costs), caused by or arising out of (i)
Licensor's use, research, or transfer of the Licensed Technology, (ii)
Licensor's performance of this Agreement, (iii) work product derived from
Licensor's research that infringes any patent, trademark, copyright, or any
other proprietary right of any third party, (iv) any actions of Licensee in
compliance with this Agreement that violate any policy, rule, or regulation of
Licensor, (v) any actions of Licensor that violate any law or regulation of any
governmental authority, or (vi) any actions of Licensor that violate any
restriction or agreement applicable to Licensor; provided, however, that (x)
such indemnity is subordinate to any insurance coverage applicable to the Claims
and applies only to the extent that the Claims exceed the limits of such
insurance coverage, and (y) any Claims resulting from the factors identified in
Subsection (A), (B) or (C) below are excluded from this indemnity:
(A) the failure of Licensee to comply with any applicable FDA or
other governmental laws, regulations or requirements;
34.
(B) Licensee's breach of any covenant or representation contained in
this Agreement; or
(C) the negligence or willful malfeasance of Licensee.
(C) Both parties agree that upon receipt of a Claim coming within the
scope of this indemnity provision, the recipient will notify the other party
promptly. Each indemnitor agrees, at its own expense, to provide skilled
attorneys to defend against any proceedings filed against the indemnitee with
respect to Claims covered by this indemnity, whether or not such proceedings are
rightfully filed; and each indemnitee agrees to give the indemnitor control of
the defense of such proceedings and to cooperate with the indemnitor in the
defense and settlement of the Claims, provided that the indemnitee may, at its
own expense, also retain separate counsel to cooperate with the indemnitor's
counsel in the defense of the Claims.
(D) Notwithstanding anything to the contrary contained in this Agreement,
Licensor shall not have any responsibility to pay any sum of money pursuant to
any indemnity to Licensee, nor shall Licensee have any right to withhold any sum
of money from Licensor, regarding any claim arising from Licensee's prosecution
or practice of a patent with respect to an invention or discovery that was not
developed by or jointly with Licensor. Further, with respect to any proposed
patent that Licensee may desire to prosecute, and that constitutes a part of
the Licensed Technology, Licensee shall, subject to the confidentiality
provisions of Section 17 hereof, furnish to Licensor a draft of Licensee's
proposed patent claims. Licensor shall then have a period of fifteen (15)
business days (unless extended by mutual written agreement) in which to comment
on specific aspects of the formulation of such claims as set forth in the
proposed patent application, and to specify to Licensee in writing the manner in
which Licensor recommends that the claims be revised. Licensee and Licensor
thereupon shall promptly
35.
discuss any differences in good faith in a diligent effort to resolve the matter
to the parties' mutual satisfaction. In the event that Licensor and Licensee are
unable to resolve their differences, then Licensor shall give Licensee prompt
written notice (preferably by telefax or facsimile transmission) concerning the
specific nature of Licensor's objections, together with a proposal containing
specific recommended language or action to be taken with respect to the
particular patent claim. Licensee shall then have the right to accept Licensor's
proposal, or to pursue the claims as objected to by Licensor. If Xxxxxxxx's
proposal is not adopted, and a third party action subsequently results with
respect to that aspect of the patent claim that was objected to by Licensor,
Licensor shall not have any duty to indemnify Licensee with respect to any
settlement payment or damages that may be payable by Licensee to the extent such
payment is attributable to that portion of the patent claim that was objected to
by Licensor.
(E) The terms Licensor and Licensee, as used in this Section 19, shall be
deemed to include the trustees, directors, officers, agents, employees, and
contractors of the respective parties, provided that the duty of indemnity shall
devolve solely upon Licensor and Licensee as entities (and not upon such
individuals).
20. GOVERNMENT REQUIREMENTS AND APPROVALS.
(A) The parties shall cooperate in complying with all domestic and foreign
laws and regulations regarding the development, manufacture, Sale and transport
of the Licensed Technology (including the Derivative Products), and nothing in
this Agreement shall be deemed to require any action in contravention of any
such law or regulation.
36.
(B) Subject to Sections 25(k) and 17, before this Agreement shall be
effective, this Agreement must be approved by the Director, Department of
Development, State of Ohio. Licensor shall furnish a letter to Licensee
warranting that such approval has been secured, and the Agreement will become
effective upon its execution, and Licensee's receipt of such letter.
21. FORCE MAJEURE.
Performance of this Agreement is subject to unavoidable delays to the
extent caused by force majeure, in the nature of war, civil unrest, labor
dispute, epidemic, natural disaster, or because of any governmental law or order
effectively suspending performance, or any other cause beyond the reasonable
control of the party affected and occurring without its fault; provided that
notice of such force majeure shall be given by the affected party to the other
party with reasonable promptness, specifying the cause of the delay, and the
affected party shall use reasonable efforts to resume performance of its
obligations. The time for performance shall be extended by an amount of time
equal to the period during which the effects of force majeure have prevented
performance.
22. ASSIGNMENTS AND AFFILIATES.
This Agreement shall not be assignable by any party without the prior
written consent of the other, except that Licensee may assign this Agreement, in
whole or in part, to any of its Affiliates, or to its successor in interest by
merger, consolidation or other acquisition (including the assignee of all or
substantially all of its assets), or to its sublicensees. In the event of such
assignment, this Agreement shall, to the extent of the interest transferred,
automatically be binding upon and inure to the benefit of such assignees and
37.
successors in interest, and they shall be required to undertake in writing to
perform this Agreement in accordance with their applicable responsibilities
hereunder.
23. ARBITRATION.
In the event of a dispute relating to this Agreement, the parties shall
endeavor to settle such dispute amicably. Failing amicable resolution, the
parties shall promptly submit such dispute to arbitration pursuant to the rules
of the American Arbitration Association ("AAA") in Cleveland, Ohio, or in an
available venue closest thereto. The decision rendered by the arbitrators shall
be final and binding, and enforceable by any court of competent jurisdiction.
The prevailing party shall be entitled to recover Arbitration Costs. At their
election the parties may jointly apply to the District Court in Cuyahoga County,
Ohio for the appointment of an arbitrator to hear and resolve the dispute, in
which event such arbitrator shall be guided by the Commercial Arbitration Rules
of the AAA. In such event, the costs associated with the application to such
Court shall be shared equally by the parties, but all other Arbitration Costs
shall be paid by the party against whom the award is rendered. The arbitrators
shall have the power to grant relief in equity as well as at law.
Notwithstanding the foregoing, this provision shall not preclude (a) any party
from seeking temporary injunctive relief from a court pending arbitration, or
(b) the parties from seeking to mediate any dispute hereunder as a more
expeditious and less expensive alternative to arbitration.
24. GOVERNING LAW.
The enforcement and construction of this Agreement shall be governed by
Ohio law.
38.
25. GENERAL PROVISIONS.
(A) INTEGRATED AGREEMENT. This Agreement, together with the Sponsored
Research Agreement and the Option Agreement (collectively, the "Agreements"),
constitute the complete understanding and agreement of the parties with respect
to the subject matter hereof, and together supersede all prior or
contemporaneous written and oral agreements, representations and understandings
between the parties with respect to the subject matter hereof. The parties
acknowledge that no representations have been made to induce execution of this
Agreement except as set forth in the Agreements. This Agreement can only be
amended or supplemented by a written instrument, duly executed on behalf of the
respective parties.
(B) SEVERABILITY AND REFORMATION. If any provision of this Agreement is
held invalid or unenforceable by a tribunal of competent jurisdiction, such
provision shall be reformed to the minimal extent necessary to render such
provision valid and enforceable. If such reformation cannot be granted, then the
invalid provision shall be deemed severable and all other provisions shall
remain in full force and effect. Notwithstanding the foregoing, if the granting
of reformation or the severance of any provision would materially destroy or
diminish the objectives of the parties or the benefits to be derived by either
party under the Agreement, then the determination that a particular provision is
invalid or unenforceable shall apply to the Agreement in its entirety.
(C) NOTICES. It is contemplated that the parties will frequently conduct
informal communications relating to the subject of this Agreement. However, all
notices and other communications between the parties with respect to specific
rights and obligations of the parties under the provisions of this Agreement
shall be in writing and shall be deemed given if delivered personally, by
courier or by facsimile transmission, telefaxed or mailed by registered or
certified mail
39.
(return receipt requested), with all facsimile, telex or postage fees paid by
the sender, to the parties at the following addresses (or at such other address
for a party as shall be specified by like notice; provided, however, that
notices of a change of address or telex or facsimile number shall be effective
only upon receipt thereof):
If to Licensor:
Director
Technology Transfer Office
Ohio University Innovation Center
Xxx Xxxxxxxxx Xxxxxx
Xxxxxx, Xxxx 00000
Attn: Xxxxx Xxxxx, Ph.D.
Facsimile: (000) 000-0000
With Copy to:
Vice President, Research and Graduate Studies
University Research Center
Ohio University
Athens, Ohio 45701
Attn: X. Xxxxx Xxxxxxx, Ph.D.
Facsimile: (000) 000-0000
If to Licensee:
Drug Development Investment Corp.
000 Xxxxxxx Xxxx
Xxxx Xxxx, Xxxxxxxxxxxx 00000
Attn: Xxxx X. Xxxxxxxx, M.D.
Facsimile: (000) 000-0000
With Copy to:
Xx. Xxxxxx X. Xxxxxxxx
Xxxxxxxx Xxxxxxx & Xxxxxxx
1800 NationsBank Tower
000 Xxxxxxxx Xxxxxx
Xxxxxx, Xxxxx 00000
Facsimile: (000) 000-0000
Notices which are mailed shall be deemed to have been delivered on the third day
after deposit in a postal depository. Records of the sender generated by the
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sender's telecopier and ancillary equipment and/or maintained in the ordinary
course of sender's business showing the recipient's telecopier number and the
date and time of transmission and number of pages transmitted shall constitute
presumptive evidence of the receipt of a telecopy for purposes of this Section.
(D) CONSTRUCTION. References to one gender shall include all other
genders; the use of singular nouns shall imply the plural and vice versa; and
words denoting persons will include corporations and vice versa where
appropriate to the context. References to Licensee shall include its Affiliates
and sublicensees where appropriate to the context.
(E) CAPTIONS. The headings used in this Agreement are solely for
convenience and shall not be considered in interpreting the provisions hereof.
(F) WAIVER. No waiver of any provision of this Agreement shall be deemed
effective unless expressly set forth in a written instrument signed by the party
against whom such waiver is to be enforced, and no failure to insist upon strict
performance of any particular provision shall preclude either party from
thereafter insisting upon strict compliance in the future with such provision or
any other provision in this Agreement.
(G) CUMULATIVE REMEDIES. All rights and remedies contained in this
Agreement are cumulative, and to the extent permitted by law any one or more of
such rights and remedies may be exercised concurrently or successively.
(H) LITIGATION COSTS. The prevailing party in any proceeding involving a
dispute relating to this Agreement shall be entitled to recover its Litigation
Costs and/or Arbitration Costs incurred in connection with the proceeding.
(I) FURTHER ASSURANCES. The parties hereto agree to execute any and all
such further documents and to take any and all such further action as may be
necessary or appropriate to effectuate the purposes of this Agreement.
41.
(J) NO PARTNERSHIP. In giving effect to this Agreement, Licensor and
Licensee shall not be deemed agents, partners, or joint ventures of each other
for any purpose. Neither party shall have the authority to enter into contract,
or to incur any expense or liability, on behalf of the other.
(K) CONFIDENTIALITY PENDING EFFECTIVENESS OF AGREEMENT. Section 17 of
this Agreement shall be effective upon signing by the parties, even pending the
acquisition of any required formal approval by any party's governing body or any
Regulatory Authority.
(L) INTEREST ON DELINQUENT OBLIGATIONS. Late payments by Licensee will
be subject to interest charges equivalent to [*] and [*] percent above the prime
rate of interest charged from time to time by the Chase Manhattan Bank, N.A. in
New York City, commencing thirty (30) days following the due date.
(M) SIGNATORY AUTHORITY. Each signatory below represents to the other
party that he/she has authority to sign for and bind the principal on whose
behalf he/she has purported to execute this Agreement.
(N) MULTIPLE COUNTERPARTS. This agreement may be executed in multiple
counterparts, all of which collectively, and each of which shall constitute one
and the same instrument.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
42.
IN WITNESS WHEREOF, the parties hereto, intending to be bound hereby,
have executed and delivered this Agreement as of the Effective Date.
OHIO UNIVERSITY AND ITS EDISON ANIMAL
BIOTECHNOLOGY CENTER
By: /s/ X Xxxxx Xxxxxxx, Ph.D.
--------------------------------------
X Xxxxx Xxxxxxx, Ph.D., Vice-President
for Research and Graduate Studies
DRUG DEVELOPMENT INVESTMENT CORP.
By: /s/ Xxxx X. Xxxxxxxx, M.D.
--------------------------------------
Xxxx X. Xxxxxxxx, M.D., President
43.
EXHIBIT A
PATENTS
[*]
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
44.
EXHIBIT B
PAYMENT SCHEDULE
The following payments shall be made by Licensee:
a. A [*] licensed to Licensee by Licensor under the terms of this
Agreement [*].
b. A [*] for [*] licensed to Licensee by Licensor under the terms of this
Agreement [*].
c. A [*] in accordance with Section 8 of the Agreement, not including
Sales of Derivative Products as part of a transfer of technology
rights to sublicensees, except as otherwise stated in the Agreement.
[*] = CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
45.