This License
Agreement (“Agreement”), made this 27th day of May,
2009 (“Effective Date”), between Echo Therapeutics,
Inc., a corporation existing under the laws of the State of
Delaware, having its principal place of business at 10 Forge
Parkway, Franklin, Massachusetts 02038 (“Licensor”),
and Ferndale Pharma Group, Inc., a corporation existing under the
laws of the State of Michigan, having its principal place of
business at 780 West Eight Mile Road, Ferndale, Michigan 48220
(“Licensee”).
A. Licensor
is engaged in the business of research, development, production and
commercialization of transdermal medical devices and
pharmaceuticals, with emphasis on (i) transdermal continuous
glucose monitoring (tCGM) systems for use in clinical settings and
by people with diabetes and (ii) transdermal drug delivery
technologies;
B. Licensor
has developed and is commercializing the Prelude Technology (as
defined below);
C. Licensor
has developed Know-How (as defined below) relating to the Prelude
Technology; and
D. Subject to
the terms and conditions of this Agreement, Licensee desires to
obtain from Licensor an exclusive license under the Patents (as
defined below) and the Know-How in order to develop, have
developed, assemble, use, market, have marketed, sell and have
sold, and export the Products (as defined below) within the scope
of the Field (as defined below) and in the Territory (as defined
below);
NOW,
THEREFORE, in consideration of the mutual promises herein
contained, it is agreed as follows:
“50%
Royalty” has the meaning given in
Section 6.2.
“510(k)
Clearance” means the 510(k) medical device clearance from the
FDA for the Prelude™ SkinPrep System, which states, inter
alia , that the labeling is substantially equivalent to that
approved by the FDA for the SonoPrep™ System in 510(k) Number
K040525.
“Affiliate” means any company,
corporation, firm, partnership or other entity that controls, is
controlled by or is under common control with the party in
question. As used in this definition, the term
“control” means the possession, directly or indirectly,
of the power to direct or cause the direction of the management and
policies of a party, whether through ownership of voting
securities, by contract, or otherwise.
“Available Product Opportunity”
means a combination of lidocaine and Azone TS™.
“Clearance” means any approvals
(including pricing and reimbursement approvals), licenses,
registrations or authorizations of any federal, state or local
regulatory agency, department, bureau or other governmental entity,
necessary for the marketing and commercial sale of the Products in
the Field in a regulatory jurisdiction including, but not limited
to, a 510(k) Clearance.
“Commercial Sale” means a commercial
sale of Product Components to a non-Affiliate third-party within
the scope of the Field in the Territory.
“Confidential Information” means,
with respect to a party, all information of any kind whatsoever,
and all tangible and intangible embodiments thereof of any kind
whatsoever, which is disclosed by such party to the other party and
is marked, identified or otherwise indicated to be confidential at
the time of disclosure to the other party. Notwithstanding the
foregoing, Confidential Information of a party shall not include
information which the other party can establish by written
documentation (a) to have been publicly known prior to
disclosure of such information by the disclosing party to the other
party, (b) to have become publicly known, without fault on the
part of the other party, subsequent to disclosure of such
information by the disclosing party to the other party, (c) to
have been received by the other party at any time from a source,
other than the disclosing party, rightfully having possession of
and the right to disclose such information, (d) to have been
otherwise known by the other party prior to disclosure of such
information by the disclosing party to the other party, or
(e) to have been independently developed by employees or
agents of the other party without access to or use of such
information disclosed by the disclosing party to the other
party.
“Contract
Year” has the meaning given in Section 6.2.
“Defense
Action” means a lawsuit or claim that arises out of
Licensee’s practice of the composition or method of preparing
the composition as set forth in one or more of the claims of the
Patents.
“Device” means a mechanical skin
ablation device including embedded software, with charging
stand.
“FDA” means the United States Food
and Drug Administration.
“Field” means the temporary
disruption of the outer layer of the skin prior to the application
of topical analgesic/anesthetic cream, for local dermal anesthesia
or analgesia prior to a needle insertion or IV
procedure.
“Final
Patent Refusal” means a final, non-appealable denial or
refusal (not subject to re-examination) to issue a patent in a
certain country by that country’s patent reviewing
body.
“Improvement Plan” has the meaning
given in Section 6.2.
“Improvements” means any
replacements, improvements or modifications to the Device or
Product Components, in each case in the Field.
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“Know-How” means trade secret and
other know-how rights in all information and data that is not
generally known (including, but not limited to, information and
data regarding formulae, procedures, protocols, techniques and
results of experimentation and testing), which is necessary or
useful to use, develop, sell, or seek Clearance for the Prelude
Technology for use in the Field.
“Joint
Inventions” means inventions, discoveries, know-how, trade
secrets, and other information, that are made jointly by the
parties in the course of the performance of this
Agreement.
“Joint
Patents” means any and all patents claiming Joint
Inventions.
“Net
Sales” means the gross amounts or cash equivalents actually
received by Licensee or its Affiliates, subsidiaries, Sublicensees
or assigns during the term of this Agreement less amounts directly
attributable to: (i) rebates actually paid or taken (including
government rebates such as Medicaid chargebacks or rebates),
administrative fees in lieu of rebates paid to managed care and
similar institutions, chargebacks and retroactive price
adjustments; (ii) refunds, credits or allowances actually
granted upon claims, rejections or returns of such sales of Product
Components, including recalls, regardless of the party requesting
the claim, rejection, or return; (iii) separately itemized
freight, postage, packaging, shipping, and insurance charges
actually incurred by Licensee for delivery of such Product
Components; (iv) taxes (but not income taxes on sales),
duties, or other governmental charges levied on or measured by the
invoiced amount for the Product Components, and actually paid by
Licensee; and (v) normal and customary trade, quantity and
cash discounts and allowances actually allowed.
“Option” has the meaning given in
Section 2.4.
“Option
Period” has the meaning given in Section 2.4.
“Patents” means the patents and
patent applications identified on attached Schedule A,
including (i) all patent applications which are renewals,
divisions, continuations, continuations-in-part, substitutions, or
additions of the patents listed on Schedule A, (ii) all
foreign counterparts of the patents listed on Schedule A, and
(iii) all patents, including reissues, re-examinations and
extensions which may issue on any of the preceding.
“Prelude
Technology” means a proprietary technology known as the
Prelude™ SkinPrep System that is capable of, among other
things, temporarily disrupting the outer layer of the skin for the
purpose of administering a topical anesthetic or analgesic and
accelerating the time to onset for topical anesthetic or analgesic
drugs including, but not limited to, lidocaine.
“Product
Components” means, collectively, an abrasive tip, a reference
electrode ring, Benzalkonium Chloride for skin preparation, and
topical 4% lidocaine cream.
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“Products” means the Device and the
products and formulations based on the Prelude Technology described
on attached Schedule B that are comprised of the Product
Components and assembled in a kit.
“Qualifying Third Party” means a
corporate partner or a licensee that receives commercialization
rights to the Product for use in the Field in the Territory under a
sublicense.
“Recipient” means the party
receiving Confidential Information.
“Sublicense Consideration” means
payments made by a Sublicensee to Licensee or its Affiliates in
consideration for a sublicense agreement to use the Patents, such
as up-front license fees, maintenance fees, milestone fees, and
minimum unearned royalties; but excluding all earned running
royalties (since earned running royalties on Licensee’s Net
Sales are payable to Licensor pursuant to
Section 6.2).
“Sublicensee” means any party, other
than an Affiliate, that obtains certain rights under this Agreement
by entering into an agreement or arrangement with Licensee, or
receives a license grant from Licensee under the
Patents.
“Sublicensee Breach” means a breach
by a Sublicensee of the payment obligations affecting Licensor or
any other material terms and conditions of a sublicense that would
constitute a breach of the terms and conditions of this Agreement
if such acts were performed by Licensee.
“Territory” means the United States
and its territories and possessions, Canada, Mexico and the United
Kingdom.
“Total
Claim Amount” means all amounts expended by Licensor and/or
Licensee in connection with any third party claim of infringement
or misappropriation in a Defense Action, including, but not limited
to, attorney fees and legal costs, and/or a royalty or other amount
that must be paid to a third party as a result of a final claim or
judgment or settlement.
“Trademarks” means the trademarks
set forth on the attached Schedule C.
2. Grant
of License; Sublicenses; Licensee’s Right of First Refusal;
Improvements; Licensor’s Supply and Sale of Certain Goods to
Licensee .
2.1 Subject to the
terms and conditions of this Agreement, Licensor grants to Licensee
the exclusive right and license under the Patents, and the Know-How
to develop, have developed, assemble, use, market, have marketed,
sell and have sold, and export the Products, within the scope of
the Field in the Territory.
2.2 Licensee may
use the Trademarks solely as necessary to use, offer for sale,
sell, lease and/or export the Products in accordance with the terms
and conditions of this Agreement. Licensee acknowledges that all
use of the Trademarks pursuant to this Agreement must be in
accordance with Licensor’s policies and must meet
Licensor’s
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quality
standards. Licensee understands and agrees that its use of the
Trademarks does not create any right, title or interest in or to
the use of the Trademarks and that all such use and goodwill
associated with the Trademarks will inure to the benefit of
Licensor. Except as expressly permitted by Licensor in writing,
Licensee shall not adopt nor attempt to register any trademark,
trade name or service mark which is confusingly similar to the
Trademarks. In addition to the Trademarks, Licensee, in
Licensee’s sole discretion, may use other trademarks to use,
offer for sale, sell, lease and/or export the Products in
accordance with the terms and conditions of this Agreement.
Licensee shall be responsible for developing and registering
trademarks for the Products, and shall own all such trademarks.
Licensee shall not be obligated to use the Trademarks, but may do
so in its sole discretion and otherwise in accordance with the
terms and conditions of this Agreement.
2.3 Licensee shall
have the unconditional right to sublicense any right granted to
Licensee under this Agreement, subject to the following
conditions:
2.3.1 In each such
sublicense, the Sublicensee will be permitted to grant further
sublicenses, and so forth for further sub-tier sublicenses, but
only on the condition that any such sublicense will be subject to
the terms and conditions of the license granted to Licensee under
this Agreement, including payments to Licensor of royalties and
other fees set forth in Section 6 based upon consideration
paid by any further Sublicensee for any such further
sublicense.
2.3.2 Licensee
will forward to Licensor, within thirty (30) days following
its execution, a fully executed, complete and accurate copy of each
sublicense granted under this Agreement. Licensor’s receipt
of such sublicense will not constitute a waiver of any of
Licensor’s rights or Licensee’s obligations under this
Agreement. Each such sublicense agreement shall be treated as the
Confidential Information of Licensee.
2.3.3 Each
sublicense will contain a right of termination by Licensee in the
event of a Sublicensee Breach. In the event of a Sublicensee
Breach, and if after a reasonable opportunity to cure as provided
in any such Sublicensee’s sublicense, such Sublicensee fails
to cure such Sublicensee Breach, then Licensee will terminate the
sublicense unless Licensor agrees in writing that such sublicense
need not be terminated. Such Sublicensee Breach and termination of
a Sublicensee’s sublicense will not affect the term of
Licensee’s license hereunder or the sublicense of any
non-breaching Sublicensee.
2.3.4 Upon
termination of this Agreement for any reason, all sublicenses will
be assigned to Licensor, and Licensor will have no greater duties
or lesser rights under such sublicenses than Licensor has under the
Agreement.
Licensee shall
have the sole discretion to determine the financial and other terms
on which any sublicenses shall be granted under this Agreement;
however, no such sublicense agreement shall alter any obligation
owed by Licensee to Licensor under this Agreement.
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2.4 For a period
of twelve (12) months following Licensee’s receipt of
notification that the 510(k) Clearance has been granted (the
“Option Period”), Licensor grants to Licensee the right
of first refusal (“Option”) to obtain an exclusive
license to develop, have developed, assemble, use, market, have
marketed, sell and have sold, and import and export all products
that fall within the definition of Available Product Opportunity.
Whether to exercise such Option is solely at the discretion of
Licensee, but if Licensee does exercise the Option, Licensee must
exercise the Option within the Option Period by payment of a
[ **
] Option fee. The Option fee shall
be paid at the time of Licensee’s exercise of the Option and
shall be fully creditable against any subsequent license fee due
for such technology. Upon payment of such Option fee, the same
rights granted in Sections 2.1 through 2.3 of this Agreement
shall be extended automatically to cover the use of the Available
Product Opportunity.
2.5 Any
Improvements to the Patents or Know-How made by or for Licensor
during the term of this Agreement shall be made available to
Licensee and be deemed included within the scope of the licensed
rights under this Agreement without any additional consideration on
the part of Licensee.
2.6 Promptly
following the Effective Date, Licensor shall disclose to Licensee
all Know-How and assist Licensee in the use of all such Know-How to
enable Licensee to perform its obligations under this Agreement. In
addition, Licensor shall make available to Licensee during the term
of this Agreement, at Licensor’s expense, upon reasonable
notice and during normal business hours, the reasonable assistance
of Licensor’s employees who are knowledgeable about the
Know-How in order to facilitate Licensee’s efforts to develop
and commercialize the Products in accordance with the terms and
conditions of this Agreement.
2.7 In
consideration for the sums paid pursuant to this Agreement,
Licensor shall not, during the term of this Agreement, conduct,
fund, license or participate in, directly or indirectly through one
or more third parties, the development, distribution or
commercialization in any country in the Territory, of any product
that can reasonably be interpreted to compete with the Products
within the scope of the Field in the Territory. Notwithstanding the
foregoing, the restrictions in this Section 2.7 shall not
apply to any product relating to Licensor’s Symphony or
AzoneTS-based technologies, as identified on attached
Schedule D.
2.8 Licensee shall
notify Licensor of the occurrence of the first Commercial Sale no
later than ten (10) days after such sale.
2.9 Exclusively
for the purposes of this Agreement, Licensor shall supply all of
Licensee’s requirements of the Devices, the abrasive tips and
the reference electrode rings pursuant to the terms and conditions
of a Supply Agreement to be negotiated in good faith and executed
by the parties subsequent to the Effective Date of this
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Echo
Therapeutics, Inc. has requested confidential treatment of this
competitive and financial information, the disclosure of which
could result in competitive harm.
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Agreement.
Licensee, at Licensee’s cost and expense, shall supply and/or
have supplied the Benzalkonium Chloride for skin preparation and
the topical 4% lidocaine cream.
3. Representations and Warranties .
Licensor
represents and warrants to Licensee that:
3.1 Licensor is
the exclusive owner or licensee of all rights to the Patents, the
Trademarks and the Know-How, has the right to grant this exclusive
license to Licensee, and has not granted to any other person, firm
or corporation any right, license, shop right, or privilege to the
Patents, the Trademarks or the Know-How within the scope of the
Field in the Territory.
3.2 Other than the
Patents, Licensor has not (i) filed, or caused to be filed,
any pending patent applications based on or claiming the Prelude
Technology for use in the Field, or (ii) obtained in its name
or caused to be obtained in the name of others any letters patent
based on or claiming the Prelude Technology for use in the
Field.
3.3 By execution
of this Agreement, Licensor does not violate any other agreements,
rights or obligations existing between Licensor and any other
person, firm, corporation or other entity.
3.4 To
Licensor’s knowledge, there are no existing or threatened
actions, suits or claims pending against Licensor with respect to
Licensor’s right to enter into and perform its obligations
under this Agreement.
3.5 Licensor is
not aware of any third party intellectual property rights that are
infringed by the Patents, the Trademarks or by the Prelude
Technology.
3.6 Licensor has
not granted any rights that currently exist under the Patents, the
Trademarks and/or the Know-How within the scope of the Field in the
Territory other than the rights granted in this
Agreement.
3.7 Licensor has
disclosed to Licensee all the information in Licensor’s
possession or control concerning side effects, injury, toxicity or
sensitivity reaction and incidents associated with the use of the
Prelude Technology in the Field, whether or not obtained from any
clinical or non-clinical studies.
3.8 This Agreement
is a legal and valid obligation binding upon Licensor and
enforceable in accordance with its terms.
Licensee
represents and warrants to Licensor that:
3.9 Licensee shall
use commercially reasonable and diligent efforts to commercialize
the Products in the Territory. Without limiting the generality of
the foregoing, Licensee shall use commercially reasonable and
diligent efforts to (i) obtain
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necessary
Clearances for the Products in the Territory, and
(ii) manufacture, market and sell the Products to meet market
needs in the Territory.
4. The
Patents and Inventions .
4.1 Subject to the
terms and conditions of this Agreement, all right, title and
interest, in and to the Patents vests solely in Licensor. Licensor
shall have the obligation to file, prosecute and maintain all
Patents in the Territory at its sole expense during the term of
this Agreement. Licensor shall pay all expenses in connection with
its filing, prosecution and maintenance of the Patents in the
Territory.
4.2 Subject only
to the rights expressly granted to the other party hereunder, each
party retains its entire right, title and interest in and to any
inventions, discoveries, know-how, trade secrets, and other
information made or developed solely by such party and/or its
consultants in the course of the performance of this Agreement
(“Sole Inventions”), and shall have the right, but not
the obligation, at its own expense, to file, prosecute and maintain
any patents claiming its Sole Inventions in all countries of the
world.
4.3 Both parties
shall jointly own any and all Joint Inventions, provided, however,
that Licensor shall be granted an exclusive fully-paid, royalty
free license to any and all Joint Inventions that are based on,
related to or in any way incorporate the Patents and/or the Prelude
Technology. Licensor and Licensee shall designate one of them to be
responsible for filing, prosecuting and maintaining any and all
Joint Patents. All costs and expenses of filing, prosecuting,
maintaining, defending and enforcing such Joint Patents will be
borne equally by both Licensor and Licensee. The party designated
to perform patenting activities shall seek the comments of the
other party and shall keep the other informed of the progress of
such prosecution by providing quarterly status reports and copies
of all correspondence between their patent counsel and the patent
offices of the countries where such applications were filed. Such
other party shall reasonably assist the party designated in the
prosecution of Joint Patents, including, without limitation, by
executing any necessary powers of attorney. Each party shall
provide the other party with quarterly written updates on its
commercialization efforts under any Joint Patents.
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