Exhibit 10.16
Execution Copy
SUPPLY AND LICENSE
AGREEMENT
This Supply and
License Agreement (hereinafter referred to as
“Agreement”), effective as of the 27
th
day of June, 2006
(the “Effective Date”), is made by and between SPI
Pharma, Inc., a Delaware corporation with its principal offices at
321 Cherry Lane, New Castle, Delaware 19720 (hereinafter referred
to as “Supplier”) and TransOral Pharmaceuticals, Inc.,
a Delaware corporation with its principal offices at 1003 W.
Cutting Blvd., Suite 110, Pt. Richmond, California 94804
(hereinafter referred to as “Purchaser”). Purchaser and
Supplier are sometimes referred to herein individually as a
“Party” or collectively as the
“Parties”.
WHEREAS, the Supplier is a
manufacturer of the Products (as defined below);
WHEREAS, the Purchaser desires to
purchase the Products from the Supplier and to obtain a license
from Supplier to use on a nonexclusive basis certain technology and
intellectual property rights associated with the Products (as more
specifically described herein, the “License”);
and
WHEREAS, Supplier is willing to
supply the Products to the Purchaser and provide the
License.
NOW, THEREFORE, in consideration of
the covenants, conditions and obligations expressed herein, and
intending to be legally bound thereby, the Parties hereto agree as
follows:
Terms defined in the preamble of
this Agreement have the meanings set forth therein, and the
following terms have the meanings set forth below.
“Affiliate” means, with respect to each Party, any company
or other entity which directly or indirectly controls or is
controlled by or is under common control with that Party. An entity
shall be regarded as in control of another entity for purposes of
this definition if it owns or controls fifty percent (50%) or
more of the shares of the subject entity entitled to vote in the
election of directors (or, in the case of an entity that is not a
corporation, for the election of the corresponding managing
authority).
“API”
means the active pharmaceutical
ingredient Zolpidem Tartrate.
“Applicable
Laws” means all
laws, ordinances, rules and regulations of any governmental or
regulatory authority that apply to the Products, Supplier’s
manufacture and supply of the Products, or this Agreement,
including without limitation (a) all applicable federal, state
and local laws and regulations; (b) the U.S. Federal Food,
Drug and Cosmetic Act (“FDCA”), (c) regulations
and guidelines of the FDA and other Regulatory Agencies, and ICH
guidelines and (d) GMP, and if applicable, current Good
Laboratory Practices and current Good Clinical Practices
promulgated by the FDA and other Regulatory Agencies.
“Facility”
means: (i) Supplier’s GMP
manufacturing facility located in Grand Haven, Michigan; or
(ii) any other GMP manufacturing facility meeting the
requirements of this Agreement, provided that Supplier has given
Purchaser at least six (6) months’ prior written notice
that it will manufacture Product for Purchaser at such other
facility.
Confidential treatment has been requested for
portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
“FDA”
means the United States Food and
Drug Administration, or any successor agency thereto.
“Finished
Product” means a
product comprising a Product together with the API, with the
quantity of API contained in each unit of such product
[***].
“GMP”
means current good manufacturing
practice and standards as provided for (and as amended from time to
time) in the Current Good Manufacturing Practice Regulations of the
U.S. Code of Federal Regulations Title 21 (Parts 11, 210, 211,
820), the FDA Guidance for Industry Q7A ICH Good Manufacturing
Practice for Active Pharmaceutical Ingredients and the IPEC (The
International Pharmaceutical Excipients Council) Good Manufacturing
Practices Guide for Bulk Pharmaceutical Excipients.
“Know-How”
means all tangible or intangible
technical, scientific and other know-how, trade secrets, knowledge,
technology, ideas, concepts, formulae, procedures, methods,
processes, protocols, analytical methods, techniques, materials and
results of experimentation and testing, including samples, data,
results, discoveries, inventions (whether patentable or
unpatentable), and other information including preclinical data and
clinical results, and other intellectual property, in written,
electronic or any other form, owned or controlled by or licensed to
(with the right to assign or sublicense) the subject Party or any
Affiliate thereof existing as of the Effective Date and that come
into existence during the Term.
“Licensed
Technology” means,
collectively, the Patent Rights and Know-How in each case that
(A) are owned by Supplier or its Controlled Affiliates or
licensed by a third party to Supplier or its Controlled Affiliates
as of the Effective Date and (B) pertain to the Product and/or
cover the development, manufacture, importation, sales or offer for
sale of the Product pursuant to the license set forth in
Section 4.1. An entity shall be regarded as a
“Controlled Affiliate” of Supplier if Supplier owns or
directly or indirectly controls fifty percent (50%) or more of
the shares of such entity entitled to vote in the election of
directors (or in the case of an entity that is not a corporation,
for the election of the corresponding managing authority) of such
entity.
“Patent
Rights” mean all
present and future patent applications and issued patents, owned,
controlled or licensed (with the right to assign or grant
sublicenses) by the specified Party or any Affiliate thereof,
including but not limited to any provisionals, divisionals,
continuations, continuations-in-part, reissues, reexaminations, or
extensions derived therefrom, as well as all foreign and
international patent applications, granted patents and all
counterparts thereof including, without limitation, substitutions,
confirmations, registrations, revalidations, supplemental
protection certificates, administrative protection certificates (or
other governmental actions) that provide exclusive rights to the
patent holders in any jurisdiction in the Territory.
“Phase III Clinical
Trial” means human
clinical trials, the principal purpose of which is to establish
safety and efficacy in patients with the disease being studied as
required in 21 C.F.R. §312.
-2-
[***] Confidential treatment has been requested
for portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
[***] means [***].
[***] means [***].
“Product”
means [***].
“Regulatory
Agency” means any
governmental regulatory authority involved in regulating any aspect
of the conduct, development, manufacture, market approval, sale,
distribution, packaging or use of the Product and/or Finished
Product, including the FDA and the European Medicines Evaluation
Agency (“EMEA”).
“Regulatory
Approval” means a
required consent, license, approval or other authorization of a
Regulatory Agency having authority over the manufacture, use,
storage, import, export, clinical testing, transport, marketing,
sale or distribution of the Product and/or Finished Product, as
applicable, in all or any portion of the Territory.
“Similar
Product” means a
proprietary product of Supplier that is functionally similar to
[***] (e.g. [***]).
“Specifications”
means the specifications for each
type of Product that are attached hereto as Exhibit A and Exhibit
B, as applicable, and which may be amended from time to time by the
mutual written agreement of the Parties.
“Term”
has the meaning given in
Section 9.1 of this Agreement.
“Territory” means [***].
|
2.
|
PURCHASE AND
SALE OF PRODUCT
|
2.1. Supply of Product .
During the Term of this Agreement, Supplier agrees to supply to
Purchaser, and Purchaser agrees to purchase from Supplier, all
quantities of each type of Product ordered by Purchaser pursuant to
purchase orders submitted to Supplier under Firm Orders in
accordance with the terms of this Agreement and subject to the
terms of Article 5 below. No change in Specifications will be made
without the mutual written agreement of Supplier and Purchaser.
Purchaser may purchase Product hereunder through its designee, and
Supplier agrees to supply Product to such designee pursuant to the
terms of this Agreement; provided, however, that Purchaser has
provided the name of such designee to Supplier in advance, and such
designee has agreed in writing with Purchaser to be bound by:
(i) the restrictions of Section 4.1 with respect to such
designee’s use of Products that it receives pursuant to this
Agreement; (ii) the confidentiality obligations of Article 10
with respect to any of Supplier’s Information that such
designee receives pursuant to this Agreement; and (iii) the
audit provisions of the last sentence of Section 6.6 with
respect to such designee’s use of Products that it receives
pursuant to this Agreement.
-3-
[***] Confidential treatment has been requested
for portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
2.2. Quantity .
2.2.1. Product purchase quantity is
projected to be [***]. The Parties acknowledge that these
quantities are estimates only and shall in no case be binding upon
Purchaser.
2.2.2. The quantity of each Product
Supplier is obligated to supply hereunder and Purchaser is
obligated to purchase hereunder for each calendar quarter shall be
as set forth in Article 5 hereof.
2.3. Orders . Orders shall be
documented by written or electronic purchase order form submitted
to Supplier [***] prior to requested delivery, and will provide for
shipment in accordance with reasonable delivery schedules and lead
times as may be agreed upon from time to time by Supplier and
Purchaser so long as the maximum lead time [***] unless otherwise
agreed to by the Parties.
2.4. Packaging . Products
shall be shipped packaged in containers in accordance with the
applicable Specifications or as otherwise agreed by the Parties in
writing. Each such container will be individually labeled with a
description of its contents, including the manufacturer lot number,
quantity and type of Product, date of manufacture and expiration
date.
|
3.
|
PRICE OF
PRODUCT; DELIVERY
|
3.1. Purchase Price . The
purchase price for each type of Product shall be [***]. Future
pricing of Product [***] will be [***]. Notwithstanding the
foregoing, if Supplier enters into a [***] arrangement with any
third party in [***] similar to this Agreement for the supply of
Product to such third party on terms or conditions [***]) [***] to
such third party than those provided to Purchaser under this Supply
Agreement, then Purchaser shall be provided [***] including,
without limitation, the [***] being provided by Supplier to such
third party.
3.2. Delivery . Supplier
shall deliver the quantities of each type of Product ordered by
Purchaser on the dates specified in Purchaser’s purchase
orders submitted in accordance with Section 2.3 above. All
Product shipments shall be delivered FOB (UCC) Supplier’s
shipping point in [***]. The carrier shall be selected by agreement
between Purchaser and Supplier, except that if no such agreement is
reached, Purchaser shall select the carrier. All Product delivered
hereunder shall be suitably packed for shipment by Supplier in
accordance with good commercial practice with respect to protection
of such Product during transportation and marked for shipment to
Purchaser’s specified receiving point.
-4-
[***] Confidential treatment has been requested
for portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
|
4.
|
LICENSE FEES
AND INTELLECTUAL PROPERTY RIGHTS
|
4.1. License . Pursuant to
the terms of this Agreement and for the Term, the Supplier hereby
grants to the Purchaser a [***] license under the Licensed
Technology (including the right to grant and authorize
sublicenses): (i) for the limited purpose of using the Product
as an ingredient in the Finished Product in the Territory; and
(ii) to manufacture, market, sell, use, import and distribute
the Finished Product in the Territory; and to have any of the
foregoing done on its behalf. Notwithstanding the foregoing,
Purchaser shall not be allowed to grant a sublicense under the
license granted to it by Supplier in this Section 4.1 unless
such sublicensee has agreed in writing with Purchaser to be bound
by: (x) the restrictions of this Section 4.1 above with
respect to such sublicensee’s use of Products that it
receives pursuant to this Agreement; (y) the confidentiality
obligations of Article 10 with respect to any of Supplier’s
Information that such sublicensee receives pursuant to this
Agreement; and (iii) the audit provisions of the last sentence
of Section 6.6 with respect to such sublicensee’s use of
Products that it receives pursuant to this Agreement. Purchaser
agrees to provide written notice to Supplier upon its grant of any
sublicenses hereunder.
4.2. License Fees . Purchaser
agrees to pay Supplier for use and sale of both types of Product a
one-time [***] license fee in the amount of [***] (the
“License Fee”) payable as provided below.
4.2.1. Supplier acknowledges that
Purchaser has already paid to Supplier a portion of the License Fee
in the amount of [***] as provided by the terms of that certain
Supply Term Sheet by and between the Parties dated
February 20, 2006.
4.2.2. Purchaser agrees to pay to
Supplier the remaining [***] of the License Fee upon the first to
occur of: (i) the first dosing of a Finished Product in a
human subject in a Phase III Clinical Trial conducted by Purchaser;
and (ii) December 31, 2006.
4.2.3. Upon the commercial launch of
a Finished Product by Purchaser, Supplier agrees to credit an
amount of [***] of the License Fee (the “Credit
Amount”) towards Purchaser’s future purchases of
Product in the form of a [***] on the amounts that would otherwise
be due to Supplier on each such future purchase by Purchaser of
Product until the Credit Amount has been fully credited against
such purchases.
4.2.4. If Purchaser determines, in
its sole discretion, that neither Product will be used in its
products containiing API due to regulatory, business or other
issues, then at Purchaser’s option either (a) the License Fee
can be applied in full by Purchaser towards the Licensing Fee
associated with any Finished Product in the Future or (b) the
Credit Amount can be applied in full by Purchaser toward
Purchaser’s purchase of any Product in the form of a [***] on
Supplier’s list price for such Product until the Credit
Amount has been fully credited against such purchases.
4.3. No Implied License .
There are no implied licenses under this Agreement, and any rights
not expressly granted to the Purchaser hereunder are reserved by
the Supplier.
-5-
[***] Confidential treatment has been requested
for portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
4.4. Intellectual Property
Rights .
4.4.1. The Parties understand and
agree that, except as otherwise expressly provided in this
Agreement, no right, title or interest is provided by one Party to
the other Party with respect to any Know-How, Patent Rights or
other intellectual property of the Party.
4.4.2. Supplier shall own the entire
right, title and interest in and to (i) all Know- How, Patent
Rights and other proprietary rights existing and owned by it on the
Effective Date and (ii) all Know-How, Patent Rights and other
proprietary rights in respect of the Product developed, discovered,
made or conceived by Supplier.
4.4.3. Purchaser shall own the
entire right, title and interest in and to (i) all Know-How,
Patent Rights and other proprietary rights existing and owned by it
on the Effective Date and (ii) all Know-How, Patent Rights and
other proprietary rights in respect of the Finished Product
developed, discovered, made or conceived by Purchaser.
|
5.
|
FORECASTS
AND FIRM ORDERS
|
5.1.
Forecasts . Upon the Effective Date of this Agreement and by
December 31 st of each year of the Term
(excluding December 31 st of the last year of the Term,
unless this Agreement is extended by the mutual written consent of
the Parties), the Purchaser shall provide Supplier with an
estimated non-binding forecast of its requirements for each type of
Product for the following calendar year. In addition, the Purchaser
shall by the end of each calendar quarter provide a rolling
forecast on a quarterly basis of its requirements for the Product
for the following four calendar quarters ( “Ql”,
“Q2”, “Q3” and “Q4”
).
5.2. Firm Orders .
5.2.1. The forecast given by
Purchaser for Ql shall constitute a firm order (“Firm
Order”) for the Product for Ql and Purchaser shall be
obligated to purchase, and Supplier shall be obligated to supply,
such quantities and types of Products pursuant to one or more
purchase orders submitted to Supplier during Ql, in each case
within the applicable ranges specified in Section 5.2.2
below.
5.2.2. It is understood and agreed
that the forecasted quantities of Product for Q2, Q3 and Q4 shall
not be binding upon Purchaser in any respect, and Purchaser shall
not be liable with respect to its good faith efforts to provide
such non-binding forecasts. Notwithstanding the foregoing, the Firm
Order for the then current Ql may not be for an amount [***] of the
immediately preceding forecast for each such calendar quarter and
Supplier shall [***] of such forecasted amount, in each case unless
otherwise agreed by the Parties in writing; provided, however, that
Supplier shall use commercially reasonable efforts to fill the
amounts of any Firm Order [***] cap described above.
-6-
[***] Confidential treatment has been requested
for portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
6.1. Specifications . The
Supplier agrees that all Product supplied hereunder shall conform
to the Specifications applicable to such Product and shall be
manufactured at the Facility in accordance with Applicable Laws,
including GMP manufacturing and record keeping
procedures.
6.2. Quality Control . Prior
to each shipment of Product, Supplier shall perform quality control
testing procedures and inspections to verify that the Product to be
shipped conforms fully to the applicable Specifications. Each
shipment of Product shall be accompanied by a certificate of
analysis in a form acceptable to Purchaser and describing all
current requirements of the Specifications, results of tests
performed certifying that the Product supplied have been
manufactured, controlled and released at the Facility in accordance
with the Specifications and Applicable Laws.
6.3. Batch Records; Samples .
Supplier shall maintain batch records sufficient to trace the
history of each batch, and representative samples from each batch
of Product manufactured hereunder, for record keeping, stability
testing, and other regulatory purposes, including as may be
required by the Specifications or Applicable Laws, for as long as
required by such Applicable Laws. Upon the request of Purchaser and
so long as Supplier is required to maintain such records, Supplier
shall provide Purchaser reasonable access to and copies of such
records and samples.
6.4. Rejected Products .
Purchaser’s receipt of Product delivered hereunder shall be
an unqualified acceptance; provided, however, that Purchaser may
reject such Product within [***] after such receipt if during such
period Purchaser or its designee discovers, upon inspection of such
Product, that such Product fails to conform with the Specifications
therefor or otherwise fails to conform to the warranties given by
Supplier in Article 12 below. Such rejection shall be accomplished
by giving written notice to Supplier and, upon request from
Supplier, Purchaser shall return the rejected Product in accordance
with Supplier’s reasonable instructions and at
Supplier’s expense, provided that such instructions comply
with all Applicable Laws. Supplier shall use its best efforts to
replace rejected Product within the [***] and in any event within
[***] after Supplier’s receipt of notice thereof. In the
event all or part of a shipment of Product is rejected prior to
Purchaser’s payment therefor, Purchaser may withhold such
payment until receipt of replacement Product that conform with the
Specifications therefor and to the warranties given by Supplier in
Article 12 below. The Parties shall use their reasonable efforts to
resolve any dispute that may arise pursuant to this Section. If the
Parties fail to agree, within [***] of Purchaser providing notice
of rejection, whether any delivery of the Products supplied by
Supplier to Purchaser conform to the Specifications therefor and
the warranties given by Supplier in Article 12, the dispute shall
be determined by an independent laboratory/expert mutually selected
by the Parties and the decision of such independent
laboratory/expert shall be final and binding on the Parties with
respect to whether the Products in question conform to the
Specifications therefor and the warranties given by Supplier in
Article 12. In the event that the independent laboratory/expert
decides that the Products in question conform to the Specifications
and the warranties given by Supplier in Article 12, such Products
shall be deemed accepted by Purchaser. In the event that the
independent laboratory/expert decides that the Products in question
do not conform to the Specifications and/or the warranties given by
Supplier in Article 12, Supplier
-7-
[***] Confidential treatment has been requested
for portions of this exhibit. These portions have been omitted from
this exhibit and have been filed separately with the Securities and
Exchange Commission.
shall use its best efforts to replace such
Products within the shortest possible time and in any event within
[***] after Supplier’s receipt of notice regarding the
independent laboratory/expert’s decision. For purposes of
clarity, only disputes between the Parties regarding conformance of
the Products as expressly described in this Section 6.4 above
shall be resolved by an independent laboratory/expert, and all
other disputes between the Parties shall be governed by the
provisions of Section 14.8 below. The independent
laboratory/expert’s fees and the prevailing Party’s
out-of-pocket costs incurred in connection with the independent
laboratory/expert’s decision shall be borne by the Party
against whom the independent laboratory/expert’s decision is
given.
6.5. Latent Defe