Exhibit 10.31
CERTAIN CONFIDENTIAL PORTIONS OF
THIS EXHIBIT WERE OMITTED AND REPLACED WITH THE SYMBOL
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS
BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING
CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE
ACT OF 1934.
SUBLICENSE
AGREEMENT
This Sublicense Agreement (this
“ Agreement ”) is made as of October 13, 2006
(the “ Effective Date ”) by and between
PharmaNova Inc. a Delaware corporation with its principal place of
business located at 50 Lucius Gordon Drive, Ste 206, West
Henrietta, NY 14586 (“ Licensor ”), and Depomed,
Inc., a California corporation with its principal place of business
located at 1360 O’Brien Drive, Menlo Park, CA 94025 (“
Licensee ”) (each, a “ Party ” and
collectively, the “ Parties ”).
1.
PREAMBLE
1.1
Licensor has
exclusively licensed the rights (with the right to sub-license) to
certain intellectual property specifically covering the use of
gabapentin for certain conditions secondary to hormonal
variation.
1.2
Licensee has in
clinical development a gabapentin product utilizing
Licensee’s proprietary drug delivery technology currently
referred to as the AcuForm technology (“ Gabapentin GR ”). Licensee
desires, pursuant to terms and subject to conditions set forth in
this Agreement, to create a unique dosage form of Gabapentin GR,
utilizing the same proprietary drug delivery technology and a
unique strength, release profile or mechanism of drug delivery
relative to Licensee’s current formulation of Gabapentin GR,
for the treatment of certain conditions secondary to hormonal
variation, and to seek to obtain regulatory approvals for such
product in the US.
1.3
Licensor desires
to grant to Licensee a license for certain of the use and
territorial rights to gabapentin held by Licensor.
NOW, THEREFORE, The Parties agree as
follows:
2.
DEFINITIONS : Terms defined in this
Article 2, and parenthetically defined elsewhere in this Agreement,
will throughout this Agreement have the meaning here or there
provided. Defined terms may be used in the singular or in the
plural, as sense requires.
2.1
“
‘098 Patent ” means U.S. Patent No.
6,310,098, including all re-examinations, reissues, supplemental
protection certificates and extensions thereof.
2.2
“
Affiliate ” means any
corporation or other business entity that controls, is controlled
by or is under common control with the Licensee or Licensor.
“Controls,” “control” or
“controlled” as used in this paragraph means direct or
indirect ownership of more than fifty percent (50%) of the voting
stock of such corporation or the ability to exclusively direct,
either directly or indirectly, the decision-making authority of
such other unincorporated business entity.
2.3
“API”
means gabapentin
[1-(aminomethyl) cyclohexaneacetic acid].
2.4
“Cancer
Indications” means treatment, diagnosis or
prevention of vasomotor symptoms associated with cancer (e.g.,
conditions such as breast, endometrial, uterine and prostate
cancer) and/or drug treatment for cancer and/or chemotherapy for
cancer.
2.5
“
Cancer Product ” means a product when
labeled for use for any of the Cancer Indications.
2.6
“
Clinical Information
” shall
mean all in-vivo or clinical, pharmacology, toxicology, safety and
efficacy data, formulary submissions, pharmacoeconomic data, Phase
I, II and III clinical data and results, and other such information
now or hereafter known and available to University, Licensor or its
Affiliates, whether generally known to others or not, which
concerns Product and does not concern PharmaNova
Product.
2.7
“Collaboration
Committee” means the committee described
in Section 6.
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2.8
“Commercialize” or
“Commercialization” means the ongoing process
and activities generally engaged in by a pharmaceutical company to
sell and market a pharmaceutical product.
2.9
“Confidential
Information” means information that is
marked as confidential, or, if orally disclosed, is indicated at
the time of disclosure as confidential and provided in written form
within thirty days. Not withstanding the foregoing, the
receiving Party will have no obligation of confidentiality relating
to any information of the disclosing Party that:
(i)
is or becomes part of the public
domain through no fault of the receiving Party;
(ii)
is known to the receiving Party
prior to the disclosure by the disclosing Party, as evidenced by
documentation;
(iii)
is independently developed by the
receiving Party without reference or use of the Confidential
Information or without any breach of this Agreement as evidenced by
documentation;
(iv)
is subsequently obtained by the
receiving Party from a duly authorized Third Party;
(v)
is publicly released as authorized
under this Agreement by the disclosing Party, its employees or
agents.
2.10
“Confidentiality
Agreement” means that certain
Confidentiality Agreement between Licensor and Licensee dated May
24, 2004.
2.11
“
Control ” or “
Controlled ” shall mean, with
respect to any intellectual property right or other intangible
property, that a Party or one of its Affiliates owns or has a
license or sublicense to such item or right, and has the ability to
grant access, license or sublicense in or to such right without
violating the terms of any agreement or arrangement with any Third
Party.
2.12
“
Diligent Efforts ” shall mean the
carrying out of obligations or tasks consistent with the
commercially reasonable practices of the pharmaceutical industry
for the development or Commercialization of a pharmaceutical
product having similar market potential or profit potential as the
Product, based on conditions then prevailing. Diligent
Efforts
3
requires that the
Party, at a minimum: (a) determine the general industry
practices with respect to the applicable activities, (b) reasonably
promptly assign responsibility for such obligations to specific
employee(s) who are held accountable for progress and monitor such
progress on an on-going basis, (c) set and consistently seek to
achieve specific and meaningful objectives for carrying out such
obligations, and (d) make and implement decisions and allocate
resources designed to advance progress with respect to such
objectives.
2.13
“FDA”
means the United
States Food and Drug Administration or any successors to its
responsibilities with respect to pharmaceutical products such as
the Products.
2.14
“First Commercial
Sale” means the initial transfer by
or on behalf of Licensee or its Sublicensees of Products in
exchange for cash or some equivalent to which value can be assigned
for the purpose of determining Net Sales Revenue.
2.15
“Government
Authority” means any court, agency,
department, authority or other instrumentality of any federal,
state, county, city or other political subdivision.
2.16
“Law” or
“Laws” means all laws, statutes,
rules, regulations, orders, judgments and/or ordinances of any
Government Authority.
2.17
“Licensed Patent”
means the
‘098 Patent.
2.18
“Licensor Patent
Rights” means any Patent Rights,
including without limitation those rights in the Licensed Patent
granted to and held by Licensor under the University License, in
the field of use of API for Menopause Indications, which rights are
owned by or Controlled by Licensor or an Affiliate of Licensor as
of the Effective Date; provided , however ,
that Licensor Patent Rights shall not include the PharmaNova Patent
Application or any Patent Rights associated therewith. All
Licensor Patent Rights currently within this definition are set
forth on Exhibit A , which exhibit shall be amended from
time to time as necessary to reflect changes or additions to the
Licensor Patent Rights.
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2.19
“Menopause
Indications” means the treatment,
diagnosis or prevention of vasomotor symptoms of hormonal variation
( e.g. , hot flashes) associated with menopause in
women.
2.20
“NDA”
means a New Drug
Application filed with the FDA with respect to a pharmaceutical
product (or similar application, if such application is no longer
available or appropriate).
2.21
“Net Sales”
means the gross
amount of monies or cash equivalent or other consideration that is
paid by Third Parties to Licensee or any of its Affiliates,
assignees, licensees, Sublicensees, transferees, distributors or
commercial partners (or their affiliates) or designees thereof for
Product by sale or other mode of transfer, in bona fide
arm’s length transactions, less the following deductions, in
each case related specifically to Product and actually allowed and
customarily taken by such Third Parties and not otherwise recovered
by or reimbursed to Licensee or any of its affiliates, assignees,
licensees, Sublicensees, transferees, distributors or commercial
partners (or their affiliates) or designees thereof:
(i) all trade, quantity and cash discounts actually allowed and
customarily taken; (ii) customary and usual credits, and allowances
actually granted and taken on account of rejections, returns or
billing errors; (iii) packing costs; (iv) transportation; and, (v)
insurance, solely related to shipping such Product
except that no deductions may be
made for commissions paid to individuals whether they be with
independent sales agencies or regularly employed by Licensee, its
Affiliates or Sublicensees, and on its payroll.
2.22
“
Patent Rights ” shall mean (i) valid
and enforceable patents, re-examinations, reissues, renewals,
extensions, supplementary protection certificates and term
restorations, any confirmation patent or registration patent or
patent of addition based on any such patent, (ii) pending
applications for patents, including without limitation
continuations, continuations-in-part, divisional, provisional and
substitute applications, and inventors’ certificates, and
(iii) all priority applications of any of the
foregoing.
5
2.23
“
PharmaNova Product
” means
any pharmaceutical product containing API as an active
pharmaceutical ingredient such that (i) the development,
manufacture, sale or use of such product in the Territory would be
covered by a Valid Claim of a Licensed Patent, and (ii) such
product or its use is described in, or is covered by one or more of
the claims of, PCT Patent Application No. PCT/US06/001887
(Pharmaceutical Formulations and Methods of Use) (the
“ PharmaNova Product
Patent Application ”).
2.24
“Phase III Clinical
Studies” means controlled human
clinical studies involving administration of a drug with the goal
of establishing that a drug is safe and efficacious for its
intended use, and to be considered as a pivotal study or studies
for submission of an NDA.
2.25
“
Product” means any pharmaceutical
product containing API as an active pharmaceutical ingredient such
that the development, manufacture, sale or use of such product for
the Menopause Indications would, but for the license granted under
this Agreement, infringe in the Territory a Valid Claim of a
Licensed Patent. Product does not include PharmaNova Products
nor any product that is Commercialized in the Territory but is not
expressly labeled or marketed for the Menopause
Indications.
2.26
“
Program ” means all activities
related to the development and commercialization of Product
performed by or on behalf of Licensee (or its Affiliates) or
Licensor (or its Affiliates) pursuant to this Agreement; provided,
however, that all activities related to the development of Products
conducted by Licensee (or its Affiliates) prior to the
Effective Date will be deemed to be conducted outside of the
Program.
2.27
“Quarter”
means each of the
three-month periods ending on March 31, June 30, September 30 and
December 31 in any calendar year.
2.28
“Regulatory
Approval” means in the United States,
written notice of marketing approval by the FDA based on approval
of an NDA and satisfaction of any related applicable FDA
registration and notification requirements (if any) which are
required before a product may be commercially sold in the United
States.
6
2.29
“
Regulatory Data ” means any
information and data necessary or useful to obtain or maintain
Regulatory Approval for the Product in the Territory, including
post-approval reports, filings and submission and shall include,
but not be limited to, any Clinical Information required for that
purpose.
2.30
“Sublicense”
means the
present, future or contingent transfer of any license, right,
option, first right to negotiate or other right granted under the
Licensor Patent Rights in whole or in part pursuant to Section 4.2;
provided, however , that the development, promotion,
distribution or marketing of the Product by a Third Party on behalf
of Licensee does not constitute a Sublicense.
2.31
“Sublicensee”
means a Third
Party that is granted a Sublicense.
2.32
“Territory”
means United
States of America and its territories including Puerto
Rico.
2.33
“Third Party”
means any
individual, estate, trust, partnership, joint venture, association,
firm, corporation, company or other entity, other than Licensor or
Licensee or any of their Affiliates.
2.34
“University”
means the
University of Rochester, located in Rochester,
New York.
2.35
“University
License” means the Exclusive Patent
License Agreement, dated August 11, 2004, between Licensor and
University, as amended by Amendment No. 1 thereto dated as of the
Effective Date, and as may be subsequently amended in accordance
with this Agreement.
2.36
“University
Provisions” means the following
provisions of this Agreement: Section 4.2 (Sublicensing);
Section 4.3 (Research License); Section 5.7.1 (Records); Section
6.2 (Product Development Diligence Obligations); Section 6.5
(Patent Marking); Section 9.2.1 (Control of Actions); Section 13.4
(Use of Names); Section 14.6 (Assumption by University); Section
15.2 (Indemnification of University); Section 15.3 (No
Consequential Damages); Section 15.4 (Insurance); and Section 15.5
(Settlements).
7
2.37
“Valid Claim”
means any claim
of an issued and non-expired patent which has not been withdrawn,
canceled, or disclaimed nor held invalid by a court, tribunal,
arbitrator or governmental agency of competent jurisdiction in a
final or unappealed or unappealable decision.
3.
UNIVERSITY CONSENT AND APPROVAL
3.1
University Approval.
Licensor has
delivered to the University a copy of this Agreement, and received
the University’s written approval of the sublicense in the
Licensor Patent Rights granted herein, and has provided Licensee
with a complete and accurate copy of such written
approval.
3.2
Consent and
Acknowledgement. Licensor has received from
the University a Consent and Acknowledgement providing that, to the
extent that any of the University Provisions are inconsistent with
any provision of the University License, the University Provisions
shall control, and that Licensee shall be a third party beneficiary
of such Consent and Acknowledgement. Licensor has provided
Licensee with a complete and accurate copy of such Consent and
Acknowledgement.
4.
LICENSE
4.1
Grant. Subject to the
terms of this Agreement and Licensee’s obligations arising
therefrom, Licensor hereby grants, effective upon Closing, to
Licensee and its Affiliates an exclusive, royalty-bearing license,
under the Licensor Patent Rights to import, develop, have
developed, make, have made, use, offer for sale and sell Product
for the Menopause Indications in the Territory.
4.2
Sublicensing . Licensee shall have
the right to Sublicense its rights to the Licensor Patent Rights,
but solely to the extent such Sublicense is consistent with the
following limitations:
4.2.1
Licensee is
responsible for its Sublicensees and must not grant any rights that
are inconsistent with the rights granted to and obligations of
Licensee hereunder. Any act or omission of a Sublicensee that
would be a breach of this Agreement if performed
8
by Licensee will
be deemed to be a breach by Licensee of this Agreement.
4.2.2
Each Sublicense
granted by Licensee must provide that the obligations of Licensee
to (i) University in the University Provisions and (ii) Licensor in
this Agreement shall be binding upon the Sublicensee as if it were
a party to this Agreement.
4.2.3
No Sublicense may
contain any provision that would cause the sublicensed rights to
the Licensor Patent Rights to extend beyond the term of this
Agreement or to extend outside the scope of the license granted to
Licensee in this Agreement.
4.2.4
Any and all
Sublicenses granted by Licensee are subject to the prior approval
of Licensor and University; such approval will not be unreasonably
withheld, delayed or conditioned, and shall be deemed granted
unless Licensor or University reasonably report within 30 (thirty)
business days of its receipt of such sublicense that such
Sublicense is unacceptable.
4.2.5
No Sublicensee
shall have the power to grant a sublicense under any
Sublicense.
4.2.6
Licensee must
promptly give Licensor and University the name and address of each
Sublicensee with whom it concludes a Sublicense, and must forward
to Licensor and University a copy of each executed Sublicense
within thirty (30) days of the date of execution of such
Sublicense.
4.3
Research License.
The license
granted to Licensee herein is subject to and restricted by a
reserved non-exclusive license, with the right to non-exclusively
sublicense, to non-profit institutions for research purposes only,
to University to make, have made, and use, but not to sell or have
sold, or license others to sell or have sold, Products.
9
5.
CONSIDERATION
As partial consideration for the
rights and licenses granted to Licensee in this Agreement, Licensee
agrees to pay the following, subject to the provisions of Section
10.1:
5.1
License Issue Fee.
Licensee
shall pay to Licensor a one-time, non-refundable, non-creditable
license issue fee of five hundred thousand US dollars ($500,000) on
the Effective Date, fifty thousand US dollars ($50,000) of which
has been paid pursuant to the letter of intent between the Parties
dated as of June 22, 2006.
5.2
Development Milestone
Payments . Milestone payments,
when made, will be non-refundable, non-recoupable and
non-creditable. Each milestone payment will be payable only
once no matter how many Products attain such specified milestone
events. Each payment is dependent upon the reaching of the
specified milestone event. In addition to (and not in lieu
of) royalty payments due under this Agreement, Licensee will pay
Licensor the following one-time development milestone payments no
later than forty-five (45) days following the occurrence of each of
the events listed below:
5.2.1
Five Hundred Thousand US dollars
($500,000) upon the dosing with Product
of the first patient in the first Phase III Clinical Study
conducted by or on behalf of Licensee or any of its Affiliates;
provided, however , that in the event this milestone
has not been reached by April 1, 2008, Licensee shall pay Licensor
$100,000 (one hundred thousand dollars) monthly towards such
milestone (up to a maximum of $500,000) until the milestone is
reached whereupon the balance of the milestone shall be immediately
paid to Licensor.
5.2.2
One Million US Dollars
($1,000,000) upon submission for review by
the FDA of the first NDA for Product in the Territory;
5.2.3
Two Million US Dollars
($2,000,000) upon receipt of the first
Regulatory Approval for Product in the United States.
10
5.2.4
Licensor will be
solely responsible for, and will satisfy in a timely manner, all
milestone payments and royalty obligations agreed by Licensor and
University in the University License.
5.3
Royalties. Licensee shall pay on
a quarterly basis to Licensor royalties on all Net Sales occurring
during the Term in the Territory in an amount comprising the
following: [* * *]. Aggregate Annual Net
Sales shall be calculated on a calendar year basis.
5.4
Commercial Milestone
Payments. Licensee shall pay
Licensor the following one-time commercial milestone payments, up
to a maximum cumulative amount of [* * *] in payments
under this Section 5.4 during the Term, upon Licensee’s
achievement of each of the following Aggregate Annual Net Sales
targets as follows: [* * *]. For example,
[* * *].
5.5
Revenue Sharing
Payments.
5.5.1
Licensee shall
pay Licensor [* * *] percent [* * *] of all
revenues received by Licensee or its Affiliates in connection with
sales of Product by Third Parties with whom Licensee has entered
into a Sublicense or an agreement for the development, promotion,
distribution or marketing of Product (“ Revenue Sharing Payments ”), such Revenue
Sharing Payments shall not exceed the amount which would be due as
royalties on such sales under Section 5.3 if such sales were made
by Licensee or its Affiliate. Revenue Sharing payments for
sales of Product by Third Parties shall equal the amount which
would be due as a royalty on such sales under Section 5.3 as if
such product sales had been made by Licensee if Licensee has an
ownership interest (whether direct or indirect) exceeding twenty
percent (20%) in such Third Party.
5.5.2
Licensee shall
pay Licensor [* * *] percent [* * *] of any
sub-license fees, milestone payments and other revenues received
by
* * * Portions of this page
have been omitted pursuant to a request for Confidential Treatment
and filed separately with the Commission.
11
Licensee as a
result of sub-licensing the rights to the Licensor Patent Rights or
entering into co-development or marketing agreements with any Third
Party.
5.6
Consultancy Retainer.
Licensee
will pay to Licensor consultancy fees of three hundred thousand US
dollars ($300,000) in consideration for the provision of consulting
services by Licensor in the amount of up to 150 person-days in
support of the development of the Product. Such consultancy shall
be performed, and Licensor’s related expenses shall be
reimbursed, pursuant to Licensee’s standard form of
consulting agreement consistent with the terms of this Agreement;
provided, however that Licensee shall pay Licensor such consultancy
fees in monthly installments, commencing on the Effective Date, of
thirty thousand US dollars ($30,000), and such payments shall be
reconciled on a quarterly basis against consulting services
actually performed. The consulting services under such
consulting agreement shall be performed by employees and/or
advisors and consultants of Licensor.
5.7
Payment and Reports.
Payments
owed pursuant to Sections 5.3 — 5.5 shall be paid by Licensee
to Licensor not later than forty-five (45) calendar days following
the end of the Quarter in which the obligation to make such payment
accrues. Each royalty payment made pursuant to Section 5.3
will be accompanied by a report in writing (the “Royalty Report” ) specifying the Quarter to
which such royalty payment applies and detailing the calculation of
the royalties due to Licensor for such Quarter (including total
invoiced amount and the total amount of the deductions from such
total invoiced amount which were taken into account in determining
Net Sales).
5.7.1
Records . Licensee will keep,
and will require any of its Affiliates and Sublicensees selling
Product to keep, for five (5) years from the date of each payment
of royalties, complete and accurate records of Net Sales of each
Product in sufficient detail to allow the royalties to be
determined accurately. Licensor will have the
12
right for a
period of five (5) years after receiving any report or statement
with respect to royalties due and payable or after delivery of such
report is required, to appoint an independent certified public
accountant with national presence and reputation that is not
Licensor’s auditor to inspect the relevant records to verify
such report or statement. Licensee will make its records and
the records of its Affiliates available (including any Net Sales
reports received from its Sublicensees selling Products) for
inspection by such independent certified public accountant during
regular business hours at such place or places where such records
are customarily kept, upon reasonable notice from the other Party,
to verify the accuracy of the reports and payments. Such
inspections may occur not more than once per calendar year.
No period may be audited more than one time pursuant to this
Section 5.7.1. The Party requesting the audit will bear all
costs and expenses associated with an audit conducted pursuant to
this Section 5.7; provided , however , that if
the designated auditor discovers an underpayment of 5% or more for
any year between the amount of any royalties Licensee has paid to
the Licensor under this Agreement, and the amount of royalties
actually owed to Licensor under this Agreement, then Licensee shall
bear all costs and expenses associated with such audit.
Licensor agrees to hold in confidence all information concerning
royalty payments and reports of Licensee, and all information
learned in the course of any audit or inspection, except to the
extent necessary for Licensor to (i) reveal such information in
order to enforce its rights under this Agreement, (ii) to
provide required information to University pursuant to the
University License; or (iii) make such disclosure as is required by
Law. The results of each inspection, if any, will be binding
on both Parties. Licensee will require substantially
the
13
same audit rights
in any Sublicense it grants hereunder in order to verify the
correctness of payments due thereunder.
5.8
Withholding Taxes.
In the
event any of the payments made by Licensee pursuant to this Section
5 become subject to withholding taxes under the Laws of any
jurisdiction, Licensee shall deduct and withhold the amount of such
taxes for the account of Licensor to the extent required by
Law. Amounts payable to Licensor shall be reduced by the
amount of taxes deducted and withheld, and Licensee shall pay the
amounts of such taxes to the proper Government Authority in a
timely manner and shall promptly transmit to Licensor an official
tax certificate or other evidence of such tax obligations together
with proof of payment from the relevant Government Authority of all
amounts deducted and withheld sufficient to enable Licensor to
claim such payment of taxes. Any such withholding taxes
required under applicable Law to be paid or withheld shall be an
expense of, and borne solely by, Licensor. Licensee will
provide Licensor with reasonable assistance to enable Licensor to
recover such taxes as permitted by Law.
5.9
No Multiple Royalties
. No
multiple royalties under Section 5.3 shall be payable because the
Product, its manufacture, use or sale is or shall be covered by
more than one Licensor Patent Right.
6.
PRODUCT DEVELOPMENT:
COLLABORATION COMMITTEE
6.1
Product Development
Obligations. Licensee shall have
control over development and Commercialization in the Territory of
the Product throughout the Term. Licensee (itself or through
an Affiliate or Third Party) will be responsible for determining
which form(s) of Products to develop, the design and completion of
formulation activities, and pre-clinical and clinical studies in
the Territory. Licensee will bear all the expenses for
Product development activities.
6.2
Product Development Diligence
Obligations .
6.2.1
Licensee, during
the Term, agrees to use Diligent Efforts to proceed with the
development, manufacture, and
14
Commercialization
of Product(s) consistent with a First Commercial Sale of Product on
or before [* * *], either by itself or through
Affiliate(s), Third Parties, or Sublicensee(s). Subject to
the obligations set forth in the immediately preceding sentence and
with respect to the development of Product, the Parties acknowledge
that it is in their mutual interest to cause the First Commercial
Sale of Product to occur on or before [* * *], and that
the development target dates set forth in Exhibit B reflect
the Parties’ desire to cause the First Commercial Sale of
Product to occur by that date, provided that all of the assumptions
set forth in Exhibit B prove to be correct in all material
respects. The Parties acknowledge that the dates set forth in
Exhibit B are target dates, and may not be achieved for
reasons that include without limitation the following: (i)
the inaccuracy of any of the assumptions set forth in Exhibit
B ; (ii) recommendations or requirements of the FDA relating to
the Product; (iii) delays in the development of the Product arising
from issues related to intellectual property, safety, clinical
trial enrollment, manufacturing, or supply. Subject to the
qualifications set forth in the immediately preceding sentence,
Licensee additionally agrees to use Diligent Efforts to meet the
Product development target dates set forth in Exhibit B
.
6.2.2
The Parties
acknowledge and agree that in the event that Licensee determines
that any of the target dates set forth in Exhibit B is not
reasonably achievable notwithstanding Licensee’s compliance
with Section 6.2.1, and the failure to achieve such target date is
reasonably likely to delay the First Commercial Sale of the
Product beyond [* * *], then Licensor and Licensee
shall meet and confer with University regarding Licensee’s
development program with respect to the Product, and request that
Licensor’s
* * * Portions of this page
have been omitted pursuant to a request for Confidential Treatment
and filed separately with the Commission.
15
obligation in the
University License to cause the First Commercial Sale of the
Product to occur on or before [* * *] be extended for a
period of time equal to the delay in the First Commercial Sale
likely to be caused by the failure to achieve such target
date. The Parties acknowledge that University’s
decision not to agree to any such extension will require a
reasonable determination on the part of University that Licensee is
not diligently pursuing the development of the Product, and that a
Third Party could develop and commercially launch an alternative
formulation of the Product (including without limitation an
immediate release formulation) more rapidly than
Licensee. Any extension beyond [* * *] of
the deadline to cause the First Commercial Sale of the Product to
occur under the University License will have the effect of
extending the [* * *] target date set forth above an
equivalent period of time.
6.2.3
Licensee
acknowledges and agrees that in connection with any assumption or
assignment of this Agreement by University, Licensee’s
obligations with respect to the development and Commercialization
of the Product in the Territory shall be as set forth in Article 6
of the University License, as set forth therein on the date hereof
(or as amended in accordance with the written approval of Licensee
subsequent to the date hereof), and such provisions shall supersede
the provisions of Section 6.2.1 above.
6.2.4
The Parties
further agree that in the event that the First Commercial Sale of
Product occurs before [* * *], then, if requested in
writing by Licensee within six (6) month following the First
Commercial Sale of Product, the Territory shall thereafter during
the Term additionally include Canada, and the Parties shall
negotiate in good faith Licensee’s obligations in respect of
the
* * * Portions of this page have been omitted
pursuant to a request for Confidential Treatment and filed
separately with the Commission.
16
development and
Commercialization of the Product in Canada, and, if agreed by the
Parties, set forth such obligations in an amendment to this
Agreement.
6.3
Collaboration
Committee. Within thirty (30) days after
the Effective Date, the Parties will form a joint committee (the
“ Collaboration
Committee ”), which will meet at
least monthly until the initiation of Phase III Clinical Trials
and, thereafter, no less frequently than quarterly until Regulatory
Approval is obtained. The Collaboration Committee will be
composed of at least two, but not more than four, representatives
from Licensee or its Affiliates and at least one, but no more than
three, representatives from Licensor. The chairperson of the
Collaboration Committee will be one of Licensee’s
representatives. The Collaboration Committee may request that
other employees or consultants of Licensee or Licensor or their
Affiliates attend its meetings to present information or
participate in discussions on an ad hoc basis as it deems
appropriate. Participation by representatives of Licensor in
the Collaboration Committee shall constitute consulting services
provided by Licensor to Licensee. The Collaboration Committee
will review and discuss the activities of the Parties with respect
to Product development, and plans for obtaining Regulatory
Approvals, Licensee will also inform the Collaboration Committee at
its meeting of then-current Commercialization plans. The
Collaboration Committee may meet in person or by telephone or video
conference. Each party will bear its own costs arising from
or associated with travel for the purpose of attending such
meetings, except that Licensor’s attendance at such meetings
may be considered consulting services for purposes of the
consultancy arrangement contemplated by Section 5.6.
6.4
Trademarks. Licensee will
determine which trademark or trademarks will be used in marketing
Products in the Territory.
6.5
Patent Marking . Licensee must mark,
and must require any Affiliate or Sublicensee to mark, any and all
material forms of Products or packaging
17
pertaining
thereto sold by Licensee (and/or by its Affiliates or Sublicensees)
in the Territory with an appropriate patent marking identifying the
Licensor Patent Rights.
6.6
Use of Regulatory Data.
Licensee
shall have the right to use any Regulatory Data concerning the
Product, which Regulatory Data is owned or controlled by Licensor
or its Affiliates, at any time after the Effective Date for the
purpose of obtaining or maintaining Regulatory Approval of the
Product in the Territory. Licensor shall (i) provide to
Licensee all Clinical Information in its possession not later than
ten (10) days after the Effective Date, and (ii) on a periodic
basis during the Term, but not less frequently than quarterly,
provide to Licensee any and all additional Regulatory Data created
subsequent to the Effective Date that is owned or controlled by
Licensor or its Affiliates.
6.7
Licensee Regulatory Data.
All
Regulatory Data concerning Product and created by or on behalf of
Licensee or its Affiliates pursuant to the Pro
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