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*** Certain information (indicated by an asterisk) has been omitted from this
document pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.
EXHIBIT 10.19
AMENDMENT 1
To the Distribution and License Agreement, dated July 19,1999 ("Agreement"), by
and between Laboratoires Xxxxxxxx X.X. ("Xxxxxxxx") and Women First Healthcare
Inc. ("WFHC") is made this 3rd day of November, 2000.
WHEREAS, the parties wish to amend certain provisions of the Agreement.
NOW THEREFORE, in consideration of the premises and of the covenants herein
contained, the parties hereto mutually agree to amend the Agreement as follows :
1. Article 1.5 of the Agreement is deleted in its entirety.
2. The following sentence is added to the end of Article 1.14 of the Agreement:
"Notwithstanding the foregoing, in the case of a Managed Care
Organization ("MCO") or Group Purchasing Organization ("GPO") contract
(the financial terms of which are provided to Xxxxxxxx for review), the
aggregate of any deductions made pursuant to subparagraphs (a) and (b)
above shall never exceed *** of such gross invoiced sales on an
annual basis under such MCO or GPO contract."
3. The following sentence is added to the end of Article 3.2 of the Agreement:
"WFHC may defer the payment of the $350,000 set forth in this Article
3.2(d) until November 15, 2001, provided that each of the following
occurs (i) WFHC submits to Xxxxxxxx the final protocol for at least one
phase IV clinical study prior to November 20, 2000, (ii) Xxxxxxxx
approves of such protocol, in its discretion, in writing, and (iii) WFHC
implements such phase IV clinical study prior to January 15, 2001. In
the event of failure of any of these conditions, then the $350,000 shall
become immediately due and payable. Upon receipt by Xxxxxxxx of the
final protocol from WFHC relating to such study, Xxxxxxxx will use its
reasonable efforts to notify WFHC of its approval of such protocol or
any concerns it may have relating to such protocol within fifteen (15)
business days of Xxxxxxxx'x receipt thereof."
4. The following provision is added to end of Article 3.3 of the Agreement:
"3.3(iii) in the case of Product sales under MCO and GPO contracts as
set forth herein, WFHC shall pay to Xxxxxxxx (in lieu of the royalty and
supply prices identified in Article 3.3(i) and 3.3(ii)) the following:
(a) in further consideration of the license granted to WFHC
herein pay to Xxxxxxxx a royalty quarterly during the
Term equal to the greater of (i) *** of Net
Sales under MCO and GPO contracts, or (ii) the floor
royalty for MCOs and GPOs equal to *** per patch for
any dosage form, based on the Product sold during the
applicable quarter (including a patent royalty equal to
*** of Net Sales under MCO and GPO
contracts), and
(b) in consideration of the supply of Product pay to
Xxxxxxxx the Shipping Costs and the greater of (i)
*** of Net Sales of the Product sold under MCO
and GPO contracts or (ii) the floor price for MCOs and
GPOs equal to *** per patch for any dosage form.
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3.3(iv) in consideration for the supply of Product which is used by WFHC
solely for the performance of Phase IV clinical studies in accordance
with Article 7.1, pay to Xxxxxxxx *** plus Shipping Costs per patch
for any dosage form. In the event that WFHC uses Product (which has
already been purchased in accordance with the terms of this Agreement)
for the performance of such Phase IV clinical studies, then Xxxxxxxx
shall issue to WFHC a credit for the difference between (i) the price
actually paid for such Product on a per patch basis, and (ii)***
per patch ("Credit"), provided that WFHC submits to Xxxxxxxx written
documentation showing that such Product was actually used in the
performance of such Phase IV clinical study. The parties agree that the
Credit, if any, shall be applied to the deferred payment of $ described
in Article 3.2(d)."
5. The first three (3) sentences of Article 3.6 of the Agreement are deleted in
their entirety and replaced by the following:
"3.6 Samples. Xxxxxxxx shall supply WFHC with a reasonable quantity of
Samples (to be agreed upon by the parties in good faith) for promotional
purposes, in the form of individual sachets containing one patch, for a
price of *** per sachet (one patch), plus Shipping Costs and (as the
case may be) final packaging costs, C.I.F. WFHC's distribution facility
in Newark, Delaware, for the 25micrograms, 37.5micrograms and
50micrograms dosage forms. The Sample price set forth herein shall only
apply to those quantities of Samples, which do not exceed (i) the
quantities identified on Appendix 1 (for Sales Year 2 and Sales Year 3),
and (ii) the quantity identified for Sales Year 3 for any single Sales
Year thereafter. Xxxxxxxx shall also supply WFHC with a reasonable
quantity of Samples of the 75micrograms and 100micrograms dosage forms
for distribution to hospitals for promotional purposes, in the form of
individual sachets containing one patch, for a price of *** per sachet
(one patch), plus Shipping Costs and (as the case may be) final
packaging costs, C.I.F. WFHC's distribution facility in Newark,
Delaware, provided that WFHC can provide written justification, using
the call records, that such Samples were actually distributed to
hospitals."
6. Article 3.7 of the Agreement is deleted in its entirety and replaced by the
following:
"3.7 Forecasts and Orders. WFHC shall provide Xxxxxxxx a written twelve
(12) month rolling forecast at least ten (10) days prior to the first
day of each calendar month ("M"), such forecast to specify the requested
quantity and shipment dates for each Product form, including Samples and
Placebo Samples. Each forecast shall be binding upon WFHC with respect
to orders forecast for the Product (including Samples and Placebo
Samples) to be delivered in the calendar months M+3, M+4 and M+5. WFHC
shall issue firm purchase orders for its requirements of Product not
less than ninety (90) days prior to the date of requested shipment.
Xxxxxxxx shall not be obligated to ship a Product by the shipment date
set forth in any purchase order which is received by Xxxxxxxx less than
ninety (90) days prior to such shipment date. Any firm purchase order
for each Product form, Sample and Placebo Sample shall amount to the
Full Lot (as defined below) for any single dosage form or Placebo
Sample. A Full Lot (except for Placebo Samples) may be comprised of
different dosage forms provided that such dosage forms constitute a Full
Lot on a percent basis, and further provided that each dosage form shall
equal, at a minimum, one-tenth of a Full Lot for such dosage form. By
way of example only, WFHC would satisfy this provision under any of the
following scenarios: (i) a purchase order for 255,000 patches of
50micrograms Product, (ii) a purchase order for 250,000 patches of
25micrograms Product, plus 200,000 patches of 25micrograms Samples, or
(iii) a purchase order for 90,000 patches of 25micrograms Product (1/5
Full Lot for 25micrograms), plus 96,000 patches of 100micrograms Product
(4/5 Full Lot for 100micrograms). Notwithstanding the foregoing, for the
Placebo Samples only, a Full Lot may never be less than 100,000 patches.
*** Certain information (indicated by an asterisk) has been omitted from
this document pursuant to a request for confidential treatment. The
omitted material has been filed separately with the Securities and
Exchange Commission.
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The term "Full Lot" as used in this Section shall mean:
------------------------------------------------------
-for the 25microgram dosage form of Product/Sample *** patches
-for the 37.5microgram dosage form of the Product/Sample *** patches
-for the 50microgram dosage form of Product/Sample *** patches
-for the 75microgram dosage form of Product/Sample *** patches
-for the 100microgram dosage form of Product/Sample *** patches
-for the Placebo Sample *** patches
Xxxxxxxx may by not more than 10% adjust the amounts of Product to be
delivered, so that such amounts correspond with one manufacturing run or
an integral number thereof. None of WFHC's standard terms of purchase
and none of Xxxxxxxx'x standard terms of sale or supply shall govern any
supply of Product (including Samples and Placebo Samples) under this
Agreement, nor shall such terms supplement or modify any terms and
conditions thereof, despite possible inclusion in any purchase order,
order confirmation or other document."
7. Except as set forth herein, the Agreement shall remain unchanged.
8. All defined terms in this Amendment 1 which are included in the Agreement
shall have the same meaning as set forth in the Agreement.
9. In the event of a conflict between the Agreement and this Amendment 1, this
Amendment 1 shall control.
IN WITNESS WHEREOF, the parties have executed this Amendment 1 as of the date
first set forth above.
LABORATOIRES XXXXXXXX X.X. WOMEN FIRST HEALTHCARE INC.
-------------------------- ---------------------------
By: By:
Title: Title:
*** Certain information (indicated by an asterisk) has been omitted from this
document pursuant to a request for confidential treatment. The omitted material
has been filed separately with the Securities and Exchange Commission.
