QuickLinks
-- Click here to rapidly navigate through this
document
Exhibit 10.43
Confidential Materials omitted and filed separately with
the
Securities and Exchange Commission. Asterisks denote
omission.
Ref.:
BIA 2-093 (Eslicarbazepine
Acetate)
Dear
Mr. Adams:
Please find
enclosed the two (2) originals of the exclusive license
agreement between SEPRACOR and BIAL ("Parties") for the license of
BIAL's proprietary compound Eslicarbazepine Acetate in the United
States of America and Canada ("License Agreement"). Please have the
enclosed documents signed by SEPRACOR and return both originals to
Bial for signature. Capitalized terms used but not otherwise
defined herein shall have the meaning set forth in the License
Agreement.
As set forth in
Section 4.2 of the License Agreement, BIAL or a BIAL Affiliate
and SEPRACOR have agreed to negotiate in good faith and enter into
an agreement, within one hundred and eighty (180) days of the
Effective Date of the License Agreement, for the supply of the BIA
2-093 Product to SEPRACOR for use, sale and distribution within the
Field and Territory (the "Supply Agreement").
In keeping with
Section 4.2 of the License Agreement, the Parties have already
negotiated certain terms of the Supply Agreement and have agreed
that the terms and conditions set forth in this letter will be
incorporated in the Supply Agreement. All references to "BIAL"
herein shall be read and interpreted as references to "BIAL or a
BIAL Affiliate" and all references to "SEPRACOR" herein shall be
read and interpreted as references to "SEPRACOR or a SEPRACOR
Affiliate".
- 1.
- Supply of BIA
2-093 Products; Price. BIAL shall manufacture or have
manufactured for SEPRACOR in the Territory the BIA 2-093 Product,
fully packaged and released for immediate commercial sale,
including physician samples ("Finished Product"), and BIA 2-093 for
clinical use ("Clinical Product"). Subject to the terms of the
Supply Agreement, SEPRACOR agrees to purchase from BIAL all of
SEPRACOR's requirements for Finished Products.
- a.
- Clinical
Supply : BIA
2-093, in the various forms that are agreed upon by the Parties,
for use in preclinical and clinical trials (including
post-marketing clinical trials) will be supplied by BIAL or a BIAL
Affiliate [**].
- b.
- Physician
Samples : Physician samples of the BIA 2-093
Product will be supplied by BIAL or a BIAL Affiliate [**]. The
packaging for physician samples will indicate that they are samples
and not for commercial sale and SEPRACOR agrees not to sell such
physician samples. Pursuant to the Supply Agreement, until [**],
there shall be no restrictions on the number of physician samples
utilized by SEPRACOR; provided
, however, that [**]. Following [**], the amount of
physician samples supplied by BIAL (as measured by the [**]) will
not exceed [**]% of the Net Sales of such BIA 2-093 Product, unless
otherwise agreed upon by BIAL.
- c.
- Commercial
Supply : SEPRACOR
will not pay a royalty on commercial sales of the BIA 2-093
Products, but will pay a transfer price (the "Transfer Price" or
"TP") on the BIA 2-093 Products in accordance with Section 2
below.
1
- 2.
- Price.
Transfer Price for the
commercial supply of 400mg, 600mg and 800mg tablets of the BIA
2-093 Product to SEPRACOR for the United States territory will be
calculated at the end of each calendar quarter as [**] percent
([**]%) of the weighted average Net Selling Price for the 400mg,
600mg and 800mg pills of the BIA 2-093 Product in such
territory; provided however that [**] and will not be [**].
- a.
- The Transfer Prices
set forth in this Section 2 are based on the assumption that
[**]. For the avoidance of doubt, the primary packaging of the BIA
2-093 Product is described on Exhibit A attached hereto.
- b.
- SEPRACOR will provide
BIAL by the [**] Business Day of first month following each
calendar quarter the weighted average Net Selling Price in US
dollars for the previous quarter sales. The [**] will always apply
to the next order of the BIA 2-093 Product.
- c.
- The supply of BIA
2-093 Product for the Canadian territory will be on terms and
conditions substantially similar to the Supply Agreement as
mutually agreed upon by the Parties, and the Parties agree to
negotiate in good faith prices, terms and conditions with [**] to
the Transfer Prices for the BIA 2-093 Product for the U.S.
territory. It is however clearly understood by both Parties that
(i) SEPRACOR shall not be under an obligation to purchase the
BIA 2-093 Product for Canada at a Transfer Price which does not
provide [**] for SEPRACOR and (ii) BIAL shall be under no
obligation to supply the BIA 2-093 Product to SEPRACOR at a
Transfer Price which does not provide [**] for BIAL.
- 3.
- Forecast and Firm
Order . Upon the
execution of the Supply Agreement and at the beginning of [**]
thereafter, SEPRACOR shall provide BIAL with a short-term rolling
[**] forecast of its estimated [**] purchases of Finished Product
(the "Forecast"). Except as set forth below, each Forecast will be
non-binding and will represent only SEPRACOR's good faith estimate
of expected orders for the Finished Product. Commencing [**] prior
to the anticipated launch date of the Product, the portions of the
Forecast set forth in Sections 3.a, 3.b and 3.c will be firm
orders and will represent SEPRACOR's commitment to BIAL to purchase
the amount of Finished Product indicated in such portion of the
Forecast:
- a.
- [**] percent
([**]%) of the first [**] of each Forecast;
- b.
- For the
[**] percent ([**]%) of the second [**] of each Forecast, and
thereafter [**] percent ([**]%) of the second [**] of each
Forecast;
- c.
- For the
[**] percent ([**]%) of the [**] of each Forecast, and
thereafter [**] of the [**] of each Forecast will be
binding.
- 4.
- Shipping and
Delivery. All
deliveries of Finished Product by BIAL shall be made [**], unless
otherwise agreed to by the Parties. Risk of loss and title shall
transfer to SEPRACOR [**]. Product will be appropriately packaged
and labeled based upon agreed upon specifications between the
Parties.
- 5.
- Acceptance and
Rejection. BIAL
will manufacture or have manufactured the BIA 2-093 Product in
accordance with the cGMP, and the requirements of the product
specifications and Quality Agreement. BIAL or a Third Party on
behalf of BIAL will conduct all quality assurance/control testing
on each lot along with the release to SEPRACOR. BIAL or a Third
Party on behalf of BIAL shall provide to Sepracor with each lot of
delivered BIA 2-093 Products (i) a Certificate of Analysis
(each, a "COA") certifying that such BIA 2-093 Products conform to
the product specifications, cGMP, the Quality Agreement, [**] are
referred to herein as, the "Release Documentation"). SEPRACOR shall
be under no obligation to accept any shipment of BIA
2-093
2
|
