CERTAIN MATERIAL (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 10.21
EXECUTION COPY
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing and Supply Agreement (the "Agreement") is entered
into as of November 15, 2001 by and between AMERICAN HOME PRODUCTS CORPORATION,
a Delaware corporation acting through its Wyeth-Ayerst Laboratories Division,
with offices at 000 Xxxx Xxxxxxxxx Xxxxxx, Xx. Xxxxxx, Xxxxxxxxxxxx 00000
("Wyeth"), and WOMEN FIRST HEALTHCARE, INC., a Delaware corporation, with
offices at 00000 Xx Xxxxxx Xxxxx, Xxxxx 000, Xxx Xxxxx, XX 00000 ("Women First"
or "Buyer").
WHEREAS, pursuant to the Asset Purchase Agreement (as hereinafter
defined) Wyeth is selling to Buyer, and Buyer is purchasing from Wyeth, certain
assets relating to the Products (as hereinafter defined) for use in the United
States, its territories and possessions, including the Commonwealth of Puerto
Rico (the "Territory"); and
WHEREAS, Buyer desires to buy from Wyeth, and Wyeth is willing to
supply to Buyer, Products for sale within the Territory, all upon the terms and
subject to the conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing recitals and the
mutual representations, warranties, covenants and agreements hereinafter set
forth, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
For the purposes of this Agreement, capitalized terms used herein have
the meaning set forth below (the singular shall be interpreted to include the
plural and vice versa, unless the context clearly dictates otherwise) or if not
defined shall have the meanings set forth in the Asset Purchase Agreement.
1.1 "Affiliate" means, in the case of either Party, any
corporation, joint venture, or other business entity which directly or
indirectly controls, is controlled by, or is under common control with that
Party. "Control," as used in this Section 1.1, means having the power to direct,
or cause the direction of, the management and policies of an entity, whether
through ownership of voting securities, by contract or otherwise.
Notwithstanding the foregoing, for purposes of this Agreement, the term
"Affiliate" does not include subsidiaries in which a Party or its Affiliates
owns a majority of the ordinary voting power to elect a majority of the board of
directors but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in effect.
1.2 "Asset Purchase Agreement" means the Asset Purchase Agreement,
dated the date hereof, by and between Wyeth and Women First, pursuant to which
Wyeth is selling to Buyer certain assets related to the Products.
1.3 "cGMP" means current good manufacturing practices of the FDA,
as set forth in 21 C.F.R. Parts 210 and 211 and all other applicable rules and
regulations, as amended from time to time and in effect during the term of this
Agreement.
1.4 "Confidential Information" means any proprietary or
confidential information of either Party disclosed to the other Party pursuant
to this Agreement, whether in written, electronic, graphic or oral form,
including without limitation the existence and substantive terms of this
Agreement. This definition of Confidential Information shall be subject to the
exceptions set forth in Section 8.1.
1.5 "Effective Date" means the date of this Agreement.
1.6 "FDA" means the U.S. Food and Drug Administration.
1.7 "FD&C Act" means the United States Food, Drug and Cosmetic Act
of 1938, as amended from time to time.
1.8 "Manufacturing Facility" means Wyeth's manufacturing facility
located in Guayama, Puerto Rico, or such other manufacturing facility approved
in writing by Buyer (such approval shall not be unreasonably withheld or
delayed).
1.9 "Methods of Analysis" means the methods of analysis for the
Products currently used by Wyeth as the same may be amended from time to time by
the mutual written agreement of the Parties.
1.10 "Party" means either Wyeth or Buyer or both, as the context
requires.
1.11 "Pharmaceutical Quality Agreement" means the agreement, dated
as of the date hereof, between Wyeth and Buyer, in the form of Exhibit B
attached hereto.
1.12 "Products" means the Products listed in Exhibit A attached
hereto.
1.13 "Regulatory Approvals" means, to the extent they relate to the
Products and to the extent owned or licensed by Wyeth, the new drug
applications, abbreviated new drug applications and new drug submissions for the
Products, all supplements thereto and all regulatory files relating thereto and
all licenses or permits issued by the U.S. Drug Enforcement Agency.
1.14 "Regulatory Authority" means any national, supra-national,
regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity
-2-
in the Territory involved in the granting of Regulatory Approvals for the
Products, including, without limitation, the FDA.
1.15 "Specifications" means the specifications for the Products
currently used by Wyeth, as the same may be amended from time to time by the
mutual written agreement of the Parties.
1.16 "Third Party" means any person or entity other than Buyer,
Wyeth, and their respective Affiliates.
1.17 "$" means United States Dollars.
ARTICLE 2
PRODUCT SUPPLY
2.1 Purchase and Sale; Requirements. (a) Wyeth shall manufacture,
package and sell to Buyer, and Buyer shall purchase from Wyeth, all such
quantities of Product as Buyer shall order from Wyeth pursuant to the terms and
conditions of this Agreement.
(b) During the term of this Agreement, Buyer shall
purchase all of its requirements for Product for sale in the Territory from
Wyeth.
(c) At Closing, Buyer shall purchase, at the transfer
prices set forth on Exhibit A of this Agreement (the "Transfer Prices"), all
finished goods inventory of the Products previously manufactured by Wyeth (other
than Synalgos(R) which will be delivered no later than December 14, 2001) which
have Wyeth-labeling affixed thereto and may sell all such Products in the
Territory with such Wyeth-labeling affixed thereto without any obligation to
sticker or otherwise alter the labeling of such Products.
(d) It is agreed and understood that Wyeth shall have the
right to reference the Regulatory Approvals in fulfilling its obligations under
this Agreement.
2.2 Rolling Forecasts. Throughout the term of this Agreement,
Buyer shall provide Wyeth with a rolling one (1) year forecast of its expected
purchases of the Products through the Termination Date. Such forecasts shall be
provided and have effect as follows:
(i) Before the Effective Date, Buyer provided
Wyeth with a written forecast of its expected
purchases for the period extending two (2) Calendar
Quarters beyond the Calendar Quarter which includes
the Effective Date.
-3-
(ii) On or before the first day of the first
Calendar Quarter following the Effective Date and
then on or prior to the first day of each subsequent
Calendar Quarter, Buyer shall provide Wyeth with a
forecast of its expected purchases of Product for the
immediately following three (3) Calendar Quarters
(each a "Forecast"). The amounts forecasted for the
first two Calendar Quarters of any such Forecast (the
"Current Two (2) Calendar Quarters") shall be fixed
with respect to the minimum amount Buyer shall
purchase from Wyeth (i.e., the minimum amount Buyer
shall forecast purchasing from Wyeth shall be the
same as set forth for such two quarters in the
immediately preceding Forecast) and may not be
revised by either party in any subsequent Forecast.
In no event shall the amount forecasted for a
Calendar Quarter be more than 200% of the amount
forecasted for the immediately preceding Calendar
Quarter. The amounts forecast for each Current Two
(2) Calendar Quarters shall bind Buyer to order from
Wyeth, and Wyeth to sell to Buyer, at least such
amounts. Notwithstanding any of the foregoing, in the
event Buyer wishes to purchase additional Product in
excess of any Forecast, it shall submit its request
as far in advance as is practicable and Seller will
use commercially reasonable efforts to produce such
additional Product; it being understood that such
additional production shall not interfere with
Seller's production of other products and provided
further that in the event that Seller accepts an
additional order, Buyer shall be required to purchase
such additional Product.
(iii) Unless mutually agreed upon by both parties,
orders shall be in full batch quantities.
(iv) Notwithstanding anything to the contrary
herein, Wyeth shall use commercially reasonable
efforts to deliver to Buyer as soon as practicable
but in no case later than December 14, 2001,
Synalgos(R) product in finished package in compliance
with the terms hereof.
(v) Notwithstanding anything to the contrary
contained herein, Wyeth shall deliver all of the
Products set forth in the initial forecast previously
submitted by Buyer to Wyeth.
2.3 Supply. (a) Other than Wyeth-labeled Product purchased at the
Closing, Wyeth will supply Buyer with finished packaged Products reflecting
Buyer's tradedress manufactured at the Manufacturing Facility, including all
labeling, branding and packaging. If, upon Buyer's request, the Parties mutually
agree to change part or all of any Product manufacturing process in accordance
with Section 6.2 hereof, Buyer shall reimburse Wyeth for all costs incurred by
Wyeth in connection with making such changes.
-4-
(b) Buyer has provided and will from time to time at its own
expense provide Wyeth with camera-ready artwork for revised Product labels
(including a new NDC number) to be printed by Wyeth to meet specifications.
Buyer shall ensure that all such artwork and information supplied by Buyer to
Wyeth for such label complies with all regulatory requirements.
(c) Buyer will be responsible for any and all incremental
costs related to the Products, including labeling, branding, packaging,
manufacturing, and/or formulary or capsule changes requested by Buyer or those
required by applicable laws or regulations. Buyer will promptly reimburse Wyeth
for the cost of any such changes, including the cost of raw materials.
2.4 Ordering and Delivery.
(a) Under the terms and conditions of this Agreement, Buyer
will purchase all of its requirements for the Products through the submission of
purchase orders (other than pilot batches to qualify a third party to produce
the Products). From time to time, Buyer shall place purchase orders with Wyeth,
in accordance with the applicable Quarterly Forecast in a format agreed upon by
the Parties, for each of the Products specifying the quantities of the Products
desired, and the place(s) to which and the manner and dates by which delivery is
to be made; said delivery dates to be no later than one hundred and twenty (120)
calendar days after the purchase order date. The Parties shall be bound by the
terms of all such purchase orders that comply with the terms of this Agreement.
In the event of any conflict between the terms of any purchase order and the
provisions of this Agreement, the provisions of this Agreement shall control.
All purchase orders shall be sent by Buyer to the attention of the following
employee of Wyeth or as otherwise instructed by Wyeth:
Xx. Xxxxxx Xxxxxxxx
Associate Director
Pharmaceutical Supply Planning Division
Wyeth-Ayerst Laboratories
X.X. Xxx 000
Xxxxx, XX 00000
FAX: (000) 000-0000
(b) All transportation costs shall be for Buyer's account.
Each shipment of any Product shall be accompanied by a Certificate of Analysis,
Certificate of Conformance and all technical documentation required by the
Pharmaceutical Quality Agreement. Wyeth shall furnish a xxxx of lading to Buyer
with respect to each shipment of Product.
(c) Title to, ownership of and risk of loss with respect to
all Products purchased and sold hereunder shall pass to Buyer FOB the
Manufacturing Facility. In the event of partial or full loss of a shipment of
Product, the Parties will cooperate to insure that notification and follow-up
with the involved ground and air carriers and customs or warehouses is made in
order to determine if such missing delivery can be located.
-5-
ARTICLE 3
QUALITY
3.1 Dating, Samples, Testing and Records.
(a) Wyeth shall obtain a representative sample (in
accordance with the requirements of the relevant Regulatory Approvals) from each
batch or lot of Product delivered to Buyer or its Affiliates hereunder. Wyeth
shall assay and analyze such samples in strict accordance with the Methods of
Analysis and shall promptly prepare a Certificate of Analysis and a Certificate
of Conformance. Such Certificate of Analysis and Certificate of Conformance
shall identify the batch or lot of Product to which it relates. Wyeth shall
provide Buyer with a copy of the Certificate of Analysis and Certificate of
Conformance. Wyeth shall not ship any Product hereunder which, as indicated by a
sample assay or analysis as set forth above, does not conform to the
Specifications. Wyeth shall make available upon Buyer's request all
documentation relative to the manufacture, packaging, testing, and release of a
batch or lot. No more than six (6) months with respect to Equagesic and four (4)
months with respect to Synalgos of the stated shelf life shall have expired upon
delivery of such Products to Buyer hereunder.
(b) Buyer may analyze the Product using the Methods of
Analysis for purposes of determining whether such Product meets Specifications
and shall report any adverse findings to Wyeth within sixty (60) days after
discovery.
(c) If the analysis or assay of a sample of the Product
performed by or for Buyer indicates that the batch or lot does not meet
Specifications and Wyeth's analysis or assay of its sample from the same batch
or lot indicates that such batch or lot does meet Specifications, a sample of
the Product shall be submitted by Buyer to a mutually agreed-to qualified
laboratory for testing to determine whether the Product conformed or did not
conform to the Specifications and the test results obtained by such laboratory
shall be final and binding upon both Parties. The fees and expenses of such
testing shall be borne by the Party ultimately determined to have incorrectly
judged whether such Product met the Specifications.
(d) In the event the laboratory test results referred to
in Section 3.1(c) indicate that the Products in question failed to meet the
Specifications or in the event the Parties agree that the Products failed to
meet the Specifications or in the event that any Product fails to meet the
minimum dating requirements set forth in Section 3.1(a), Buyer shall return the
non-conforming Products to Wyeth, at Wyeth's expense, and in accordance with
Wyeth's instructions and Wyeth shall, at Buyer's option (i) give Buyer full
credit or a cash refund or (ii) furnish conforming replacement Products in
substitution of any Products which did not conform to Specification or to the
minimum dating requirements, as soon as reasonably possible (but in no event
later than 120 days) and at no additional cost to Buyer. Wyeth shall arrange for
shipment of the non-conforming and/or replacement Products, pay all delivery,
transportation, duties, insurance and other costs and shall be liable for any
losses of such replacement product with respect to such shipment during
delivery. All Product that does not conform to the Specifications or to the
minimum dating requirements shall be destroyed by Wyeth at Wyeth's sole cost and
-6-
expense in compliance with all applicable laws and Wyeth shall supply Buyer with
a certificate affirming that such destruction has been so performed.
(e) Wyeth shall retain records and retention samples of
each batch of Products delivered hereunder for at least twelve (12) months after
the expiration date of each such batch (or such longer period as may be required
by any Regulatory Approval or Regulatory Authority) and shall make the same
available to Buyer upon written request. Retention samples shall only be
destroyed after the required holding period and then only after reasonable prior
written notice to Buyer.
3.2 Recall and Seizure.
(b) Each Party shall keep the other Party promptly and
fully informed of any notification or other information whether received
directly or indirectly which might affect the marketability, safety or
effectiveness of Products and/or which might result in the recall or seizure of
Products.
(c) Within one (1) business day of a determination that a
Product withdrawal or a recall of Products may be necessary and prior to
notifying the FDA or any Regulatory Authority, Buyer shall notify Wyeth so that
Wyeth may participate in a decision whether the Products shall be withdrawn or
recalled, but Buyer shall make the final decision whether the Products are
withdrawn or recalled. Wyeth shall reasonably assist Buyer in Buyer's
investigation to determine the cause and extent of the problem.
(d) If Wyeth independently believes that a recall or
Product withdrawal may be necessary or appropriate, Wyeth shall promptly notify
Buyer of Wyeth's belief and the Parties shall fully cooperate with each other
concerning the necessity and nature of such action, but it shall be Buyer's
ultimate decision and responsibility whether to recall the Products.
(e) Wyeth shall perform any withdrawal or recall of
Products under its control, and Buyer shall perform any withdrawal or recall of
the Products under its control.
(f) In the event of any "recall" or "seizure" arising out
of or resulting from Wyeth's breach of any provision of this Agreement
(including, without limitation, a batch or lot that does not meet
Specifications), Wyeth shall, at the election of Buyer, either:
(i) supply Products, without charge to Buyer, in
an amount sufficient to replace the amount
of Products recalled or seized; or
(ii) refund to Buyer, or give credit to Buyer
against outstanding receivable due from
Buyer or against the purchase price of
Products to be delivered to Buyer in the
future, in amounts equal to Wyeth's purchase
price paid by Buyer for Products so recalled
or seized and all transportation costs and
export or import duties
-7-
incurred by Buyer and not recovered by Buyer
in respect of such recalled or seized
Products.
(g) In the event of any such recall or seizure arising
out of or resulting from Wyeth's breach of any provision of this Agreement
(including, without limitation, a batch or lot that does not meet
Specifications), Wyeth shall pay to Buyer, in addition to the amounts set out in
this Section 3.2, Buyer's out-of-pocket expenses incurred in connection with
such recall or seizure including loss of Products.
(h) For purposes of this Section 3.2 "recall" means any
action by Buyer or any Affiliate of Buyer to recover title to or possession of
Products sold or shipped to Third Parties. The term "recall" also includes the
failure by Buyer or its Affiliates to sell or ship Products to Third Parties
that would have been subject to recall if it had been sold or shipped. For
purposes of this Section 2.4, "seizure" means any action by any government
agency to detain or destroy Products or prevent release of Products.
3.3 Representations and Warranties. Wyeth represents and warrants,
with respect to each delivery of Products (other than with respect to Product
labeling and other obligations of Buyer specified herein for which Wyeth makes
no representation or warranty) hereunder, that:
(i) Products delivered hereunder meet the Specifications,
are in compliance with all Regulatory Approvals, and
are not adulterated or misbranded within the meaning
of the FD&C Act;
(ii) Products delivered hereunder are free from all liens,
charges, encumbrances and security interests;
(iii) Products delivered hereunder have been manufactured,
packaged, labeled, stored and loaded for shipment in
conformity with all applicable laws, including those
relating to the environment, occupational health and
safety and the disposal of wastes and in conformity
with cGMP;
(iv) Wyeth did not use in any capacity the services of any
person debarred under the U.S. Generic Drug
Enforcement Act, 21 USA ss.335a(k)(l) and further it
did not use any person who has been convicted of a
crime as defined under the Generic Drug Enforcement
Act in connection with the Products or any service
rendered to Buyer; and
(v) the manufacture, importation, sale, offer for sale or
use of Products does not infringe any patent or other
proprietary or protected right.
ARTICLE 4
-8-
PRICE AND PAYMENT
4.1. Price. (a) Wyeth shall invoice Buyer for each Product at the
price equal to the Initial Transfer Prices set forth on Exhibit A attached
hereto for all finished goods inventory on hand as of the Closing Date and to be
sold to Buyer through December 31, 2001, which such prices shall be fixed and
shall not change during 2001.
(b) Product sold by Wyeth to Buyer under this Agreement during 2002
shall be sold at the 2002 Transfer Prices also set forth on Exhibit A, which
such prices shall be fixed and shall not change during 2002.
(c) Products sold by Wyeth to Buyer under this Agreement during 2003
shall be sold at Transfer Prices equal to Wyeth's standard cost of production
plus ***. Standard cost shall be calculated in a manner consistent with the
calculation of standard cost for the 2001 and 2002 Transfer Prices set forth
herein.
(d) Products sold by Wyeth to Buyer at any time under this Agreement in
bulk form pursuant to Buyer's request shall be sold at Transfer Prices equal to
Wyeth's standard cost of production plus * * * . Standard cost shall
be calculated in a manner consistent with the calculation of standard cost for
the 2001 and 2002 Transfer Prices set forth herein.
4.2. Payment. Buyer shall pay each invoice for Products shipped
hereunder in U.S. dollars no later than thirty (30) days after the later of (i)
receipt of the invoice and (ii) the receipt of the Products. In the event that
Buyer is late in paying any sums due hereunder, Wyeth shall be entitled to
charge Buyer interest at the prime lending rate quoted from time to time by
Chase Manhattan Bank N.A. from the date payment was first due until the date of
payment of such monies.
ARTICLE 5
TERM AND TERMINATION
5.1 Term. This Agreement shall commence on the Effective Date and
continue in effect for a period of up to the earlier of (i) twenty-four (24)
months from the Effective Date, or (ii) the successful transfer of the
manufacture, finishing and packaging of the Products to Buyer or a third party
as selected and qualified by Buyer, which transfer Wyeth hereby agrees to
cooperate with in all reasonable and timely respects.
5.2 Early Termination.
(a) Buyer may on written notice to Wyeth terminate this
Agreement immediately if any Regulatory Agency takes any action, the result of
which is to prohibit or restrict the manufacture, formulation, packaging,
labeling, storage, importation, sale, offer for
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-9-
sale or use of the Products or any bona fide claim is made that the manufacture,
formulation, packaging, labeling, storage, importation, sale, offer for sale or
use of any of the Products infringes any patent or other proprietary or
protected right.
(b) If either Party shall at any time fail to discharge
any of its material obligations hereunder and shall fail to correct such default
within forth-five (45) days after the other Party shall have given notice to it
thereof, or if the default is of a type or nature that cannot be cured within
forty-five (45) days, and the breaching Party shall fail to adopt a plan to
remedy such default within said forty-five (45) days that is reasonably
acceptable to the aggrieved Party, the aggrieved Party shall be entitled to
notify the other Party that it intends to terminate this Agreement unless such
default is corrected and may so terminate ten (10) days after such end of such
forty-five (45) day period if such default is continuing.
(c) In the event that either Party by voluntary or
involuntary action goes into liquidation, dissolves or files a petition for
bankruptcy or suspension of payments, is adjudicated bankrupt, has a receiver or
trustee appointed for its property or estate, becomes insolvent or makes an
assignment for the benefit of creditors, the other Party shall be entitled by
notice in writing to such Party to terminate this Agreement forthwith.
5.3 Survival. The following provisions shall survive the
expiration or termination of this Agreement: Sections 3.1, 3.2, 3.3, 4.3, 4.4
and 5.3 and Articles 7 and 8.
5.4 Effect of Termination. Termination or expiration of
this Agreement, in whole or in part, shall be without prejudice to the right of
either Party to receive all payments accrued and unpaid at the effective date of
such termination or expiration, without prejudice to the remedy of either party
in respect to any previous breach of any of the representations, warranties or
covenants herein contained and without prejudice to any other provisions hereof
which expressly or necessarily call for performance after such termination or
expiration. Upon termination Buyer will purchase from Wyeth all residual
inventories of raw material and work in progress at cost (to the extent that the
level of such raw materials and work in progress is reasonably consistent with
the Forecasts provided by Buyer to Wyeth pursuant to Section 2.2 unless a higher
level of such materials is requested by Buyer) and finished packaged Products at
the then-current Transfer Prices.
ARTICLE 6
ADDITIONAL AGREEMENTS
6.1 Inspection Rights.
(a) Upon reasonable prior notice given by Buyer in
writing to Wyeth, Wyeth shall permit Buyer or its designee (reasonably
acceptable to Wyeth) at least once per calendar year to inspect that portion of
the Manufacturing Facility where the Products are manufactured, tested or stored
to evaluate Wyeth's work practices, supporting systems, documents and records
-10-
associated with the Products and make such copies of the documents as reasonably
necessary for the purpose of assessing Wyeth's compliance with applicable laws
and cGMP and Buyer's quality standards; provided that Buyer or its designee
shall have the right to perform additional inspections, including any necessary
follow-up visits, to confirm pre-approval readiness before any regulatory
submission is made to FDA, the timing and frequency of such inspections shall be
mutually agreed to by the Parties. Such inspections shall be conducted during
ordinary business hours and shall not unreasonably interfere with Wyeth's normal
business operations. Such inspections shall take place in a timely manner and
shall be permitted to take place during manufacturing and testing of the
Products.
(b) Wyeth shall, within three (3) days, notify Buyer of
any inspection by the FDA of the Manufacturing Facility where Products are
manufactured and shall furnish Buyer with copies of all reports and analyses
relating to such inspections where the inspections involve Products, their
ingredients or areas of the Manufacturing Facility used to manufacture Products,
including any FDA Form 483 Observations, Warning Letter (or equivalent) or
associated correspondence to and received from the FDA or any Regulatory
Authority within seven (7) days of receipt and in addition shall provide a
facsimile copy within seventy-two (72) hours to Buyer. If such inspections are
scheduled or conducted with advance notice, Wyeth shall advise Buyer in writing,
by facsimile or by telephone, as appropriate, and Buyer shall have the option to
attend at the time of such inspection. Duplicate samples of Products given to
government agents shall be provided to Buyer, as well as duplicates of
photographs, if any, taken during the inspection. Wyeth shall allow Buyer to
assist in any response to the FDA including review of any written response made
to the FDA by Wyeth at Buyer's discretion.
(c) Neither the inspection rights granted to Buyer
pursuant to this Section 6.1, nor any inspection performance by or on behalf of
Buyer, shall impose any liability on Buyer or relieve Wyeth from any liability
that it may have hereunder or otherwise with respect to the operation of its
facilities and/or the manufacture of the Products.
(d) Subject to Section 6.1(e) hereof and the Asset
Purchase Agreement, all information disclosed to Buyer hereunder shall be
subject to the confidentiality provisions set forth in Article 8. All
information obtained during an inspection may be used only for the purpose of
checking the compliance of Wyeth to cGMP and to other applicable regulations.
(e) During the term of this Agreement (if requested by
Buyer in connection with the transfer of the manufacture, finishing and
packaging of the Products to Buyer or a Third-Party as selected and qualified by
Buyer) or during the period of time beginning on the date this Agreement is
terminated (if not so requested by Buyer during the term of this Agreement) and
continuing for three months after the date this Agreement is terminated, Wyeth
shall provide Buyer with reasonable transitional services with respect to the
Product and/or the Know-how necessary to transfer the business of manufacturing,
finishing and packaging the Products to Buyer, including without limitation,
transferring to a Third-Party the manufacture, finishing and packaging of the
Products. Any Third-Party to whom the transfer of the manufacture, finishing and
packaging of the Products is made may use, for the purposes of manufacturing the
Products, all information disclosed to it or to Buyer under this Agreement.
-11-
(f) Wyeth shall conduct its manufacturing operations
hereunder in a safe and prudent manner, in compliance with all applicable laws
and regulations (including, but not limited to, those dealing with occupational
safety and health, those dealing with public safety and health, those dealing
with protecting the environment, and those dealing with disposal of wastes), and
in compliance with all applicable provisions of this Agreement. Wyeth shall
obtain all necessary registrations and permits pertaining to activities
contemplated by this Agreement. To the extent necessary for the registration or
licensing of Products by Buyer, Wyeth shall permit the inspection of its
premises by FDA.
6.2 Changes to Specifications, Methods of Analysis and/or
Manufacturing Process.
(a) In the event Wyeth or Buyer wishes to change the
Specifications or Methods of Analysis, or in the event Wyeth or Buyer is
required to change the Specifications or Methods of Analysis pursuant to
applicable laws or in response to the order or request of the Regulatory
Authority the following provisions shall apply:
(i) The requesting Party shall promptly advise
the other Party in writing of any such
change(s) to the Specifications or Methods
of Analysis and Wyeth shall promptly advise
Buyer as to any scheduling adjustments that
may result from such change(s), if any.
(ii) Wyeth shall cooperate with Buyer in good
faith to implement all changes to the
Specifications or Methods of Analysis as
soon as practicable after notice thereof.
(b) Wyeth shall not change the process for manufacturing,
or the source of raw materials for, the Products without the prior written
consent of Buyer, which consent shall not be unreasonably withheld or delayed.
The qualification costs of such changes (including without limitation changes in
the source of raw materials), initiated by Wyeth, shall be borne by Wyeth.
(c) Wyeth shall not change any vendor or contract
supplier of raw materials or primary packaging components used in the
manufacture of the Products without the prior written consent of Buyer, which
consent shall not be unreasonably withheld or delayed.
6.3 Pharmaceutical Quality Agreement. On the Effective Date, the
Parties shall execute and deliver to each other the Pharmaceutical Quality
Agreement.
6.4 Adverse Drug Experience Reporting. Each Party agrees to
promptly provide the other Party with information in accordance with the Adverse
Event Reporting Procedures (as may be amended from time to time upon mutual
agreement) set forth in Exhibit C.
-12-
ARTICLE 7
INDEMNIFICATION
7.1 Notice and Assistance. Each Party shall promptly notify the
other, in writing, if it learns of any litigation, claim, administrative or
criminal proceedings (collectively "Actions"), asserted or threatened against
such Party (the "Aggrieved Party") for which such Party is entitled to
indemnification hereunder from the other Party. With respect to any such Action,
the other Party shall, at no out-of-pocket expense to it except as otherwise
provided in this Article 7, reasonably cooperate with and provide such
reasonable assistance to such Aggrieved Party as such Aggrieved Party may
reasonably request. Such reasonable assistance may include, without limitation,
providing copies of all relevant correspondence and other materials that the
Aggrieved Party may reasonably request; provided, however, that any Confidential
Information so provided shall be treated in accordance with the provisions of
Article 8 hereof.
7.2 Indemnification by Buyer. Buyer shall indemnify, defend and
hold harmless Wyeth and its Affiliates and each of its and their respective
employees, officers, directors, agents, controlling persons and successors and
assigns (each, a "Wyeth Indemnified Party") from and against any and all
liability, loss, damage, cost, and expense (including reasonable attorneys'
fees) (collectively, a "Liability") which the Wyeth Indemnified Party may incur,
suffer or be required to pay resulting from or arising in connection with
promotion, distribution, marketing or sale of the Products by Buyer.
Notwithstanding the foregoing, Buyer shall have no obligation under this
Agreement to indemnify, defend or hold harmless any Wyeth Indemnified Party with
respect to any Liability covered by Section 7.3 or which results from willful
misconduct or negligent acts or omissions of Wyeth, its Affiliates, its
sublicensees, or any of their respective employees, officers, directors, agents,
controlling persons or successors and assigns.
7.3 Indemnification by Wyeth. Wyeth shall indemnify, defend and
hold harmless Buyer and its Affiliates, and each of its and their respective
employees, officers, directors agents, controlling persons and successors and
assigns (each, a "Buyer Indemnified Party") from and against any Liability which
the Buyer Indemnified Party may incur, suffer or be required to pay resulting
from or arising in connection with (i) the breach by Wyeth of any representation
or warranty, or the failure by Wyeth to perform any covenant, contained in this
Agreement; or (ii) the manufacture of Products. Notwithstanding the foregoing,
Wyeth shall have no obligation under this Agreement to indemnify, defend, or
hold harmless any Buyer Indemnified Party with respect to any Liability which
results from willful misconduct or negligent acts or omissions of Buyer, its
Affiliates or any of their respective employees, officers, directors, agents
controlling persons or successors and assigns.
7.4 Conditions to Indemnification. The obligations of the
indemnifying Party under Sections 7.2 and 7.3 are conditioned upon the delivery
of written notice to the indemnifying Party of any potential Liability promptly
after the indemnified Party becomes aware of such potential Liability; provided,
that the failure of the Aggrieved Party to give such notice or any delay thereof
shall not affect the Aggrieved Party's right to indemnification hereunder,
except to
-13-
the extent that such failure or delay impairs the indemnifying Party's ability
to defend or contest any such Liability. The indemnifying Party shall have the
right to assume the defense of any suit or claim related to the Liability. If
the indemnifying Party defends the suit or claim, the indemnified Party may
participate in (but not control) the defense thereof at its sole cost and
expense. If the Indemnifying Party shall not assume the defense of any such suit
or claim related to the Liability, the Aggrieved Party may defend against such
suit or claim in such manner as it may deem appropriate and, unless the
Indemnifying Party shall deposit with the Aggrieved Party a sum equivalent to
the total amount demanded in such suit or claim or shall deliver to the
Aggrieved Party a surety bond in form and substance reasonably satisfactory to
the Aggrieved Party in such amount, the Aggrieved Party may settle such suit or
claim on such terms as it may deem appropriate, and the Indemnifying Party shall
promptly reimburse the Aggrieved Party for the amount of all Liabilities
incurred by the Aggrieved Party in connection with the defense against or
settlement of such suit or claim. If no settlement of such suit or claim is
made, the Indemnifying Party shall promptly reimburse the Aggrieved Party for
the amount of any Liabilities incurred by the Aggrieved Party in the defense
against such suit or claim.
7.5 Settlements. Neither Party may settle a claim or action
related to a Liability, without the written consent of the other Party, if such
settlement would impose any monetary obligation on the other Party or require
the other Party to submit to an injunction or otherwise limit the other Party's
rights under this Agreement or otherwise. Except as otherwise expressly set
forth in this Article 7, any payment made by a Party to settle any such claim or
action shall be at its own cost and expense.
7.6 Limitation of Liability. (a) With respect to any claim by one
Party against the other Party arising out of the performance or failure of
performance of the other Party under this Agreement, the Parties expressly agree
that the liability of such Party to the other Party for such breach shall be
limited under this Agreement or otherwise at law or equity to direct damages
only and in no event shall a Party be liable for punitive, exemplary or
consequential damages; provided, however, that such limitation shall not apply
with respect to the obligations of either Party to indemnify the other under
Sections 7.2 or 7.3 hereof in connection with a Liability to a Third Party.
(b) ***
ARTICLE 8
CONFIDENTIALITY
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-14-
8.1 Nondisclosure Obligation. Both Buyer and Wyeth shall use only
in accordance with this Agreement and shall not disclose to any Third Party any
Confidential Information received by it from the other Party pursuant to this
Agreement, without the prior written consent of the other Party. The foregoing
obligations shall survive for a period of five (5) years after the termination
or expiration of this Agreement. These obligations shall not apply to
Confidential Information that:
(i) is known by the receiving Party at the time of its
receipt, and not through a prior disclosure by the
disclosing Party, as documented by business records;
(ii) is at the time of disclosure or thereafter becomes
published or otherwise part of the public domain
without breach of this Agreement by the receiving
Party;
(iii) is subsequently disclosed to the receiving Party by a
Third Party who to the knowledge of the receiving
party has the right to make such disclosure;
(iv) is developed by the receiving Party independently of
the Confidential Information received from the
disclosing Party and such independent development can
be documented by the receiving Party; or
(v) is required by law, regulation, rule, act or order of
any governmental authority or agency to be disclosed
by a Party, provided that notice is promptly
delivered to the other Party in order to provide an
opportunity, if practicable, to seek a protective
order or other similar order with respect to such
Confidential Information and thereafter the
disclosing Party discloses to the requesting entity
only the minimum Confidential Information required to
be disclosed in order to comply with the request,
whether or not a protective order or other similar
order is obtained by the other Party.
8.2 Permitted Disclosures. Confidential Information may be
disclosed to employees, agents, consultants, sublicensees or suppliers of the
recipient Party or its Affiliates, but only to the extent required to accomplish
the purposes of this Agreement and only if the recipient Party obtains prior
agreement from its employees, agents, consultants, sublicensees, suppliers or
Third Party manufacturers to whom disclosure is to be made to hold in confidence
and not make use of such Confidential Information for any purpose other than
those permitted by this Agreement. Each Party will use a reasonable standard of
care to ensure that such employees, agents, consultants, sublicensees, suppliers
or Third Party manufacturers do not disclose or make any unauthorized use of the
Confidential Information.
8.3 Disclosure of Agreement. Neither Buyer nor Wyeth shall release
to any Third Party or publish in any way any non-public information with respect
to the terms of this Agreement or concerning their cooperation without the prior
written consent of the other, which consent will not be unreasonably withheld or
delayed, provided, however, that either Party may
-15-
disclose the terms of this Agreement to the extent required to comply with
applicable laws, including, without limitation the rules and regulations
promulgated by the United States Securities and Exchange Commission (the "SEC"),
provided, however, that prior to making any such disclosure, the Party intending
to so disclose the terms of this Agreement shall (i) provide the nondisclosing
Party with written notice of the proposed disclosure and a opportunity to review
and comment on the intended disclosure which is reasonable under the
circumstances and (ii) shall seek confidential treatment for as much of the
disclosure as is reasonable under the circumstances, including, without
limitation, seeking confidential treatment of any information as may be
requested by the other Party. Notwithstanding the foregoing, Wyeth acknowledges
and agrees that Buyer may publicly file a copy of this Agreement, the Asset
Purchase Agreement and each other agreement related to the transactions
contemplated thereby as an exhibit to its reports with the SEC if Buyer
determines such filing to be necessary, provided that Buyer shall take, in
consultation with Wyeth, all reasonable and lawful actions to obtain
confidential treatment with respect to the provisions of this Agreement, the
Asset Purchase Agreement and each other agreement related to the transactions
contemplated thereby reasonably deemed to be competitively sensitive or
confidential information. Notwithstanding any other provision of this Agreement,
each Party may disclose the terms of this Agreement (i) to one or more Third
Parties and/or their advisors in connection with a proposed spin-off, joint
venture, divestiture, merger or other similar transaction involving all, or
substantially all, of the assets or business of the disclosing Party to which
this Agreement relates or (ii) to lenders, investment bankers and other
financial institutions of its choice solely for purposes of financing the
business operations of such Party, either (a) upon the written consent of the
other Party or (b) if the disclosing Party obtains a signed confidentiality
agreement with such Third Parties with respect to such information on terms no
less restrictive than those contained in this Article 8.
8.4 Publicity. Subject to Section 8.3, all publicity, press
releases and other announcements relating to this Agreement or the transactions
contemplated hereby shall be reviewed in advance by, and shall be subject to the
written approval of, both Parties.
ARTICLE 9
GENERAL
9.1 Force Majeure. If the production, delivery, acceptance, or use
of Products specified for delivery under this Agreement, or the performance of
any other obligation of one of the Parties hereunder is prevented, restricted or
interfered with by reason of any contingency beyond such Party's control, such
as strikes or other work stoppage, lock-outs, riots, wars (whether war is
declared or not), acts of God, invasion, fire, explosions, floods, storms, delay
of carrier, and acts of government or governmental agencies or
instrumentalities, and without the fault or negligence of such Party, the Party
so affected, upon prompt notice to the other Party, shall be excused from
performing such obligation during the continuance of such contingency. If such
contingency continues for a period of ninety (90) consecutive days or more, the
other Party may terminate this Agreement by notice in writing.
-16-
9.2 Representation by Legal Counsel. Each Party hereto represents
that it has been represented by legal counsel in connection with this Agreement
and acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this Agreement, the
Parties agree that no presumption shall exist or be implied against the Party
which drafted such terms and provisions.
9.3 Assignment.
9.3.1 Assignment by Wyeth. Wyeth may assign this Agreement
to any of its Affiliates, for so long as they remain
Affiliates, provided, however, that such assignment
shall not relieve Wyeth of its responsibilities for
performance of its obligations under this Agreement.
In addition, Wyeth may assign this Agreement in
conjunction with a merger or acquisition of Wyeth to
the successor to or transferee of all or
substantially all of its assets, provided, that such
successor or transferee expressly assumes Wyeth's
obligations under this Agreement, the Asset Purchase
Agreement and the Pharmaceutical Quality Agreement in
a writing delivered to Buyer. Wyeth may not otherwise
assign this Agreement without Buyer's prior written
consent, not to be unreasonably withheld. Buyer shall
respond in writing to such written requests by Wyeth
for assignment within thirty (30) days from such
request.
9.3.2 Assignment by Buyer. Buyer shall not assign this
Agreement to any Third Party other than to an
Affiliate (provided that Buyer shall remain
responsible for any breach of this Agreement by its
Affiliate) or to an assignee of all of the goodwill
and entire business or assets of Buyer, without the
prior written consent of Wyeth, which consent will
not be unreasonably withheld or delayed.
9.3.3 Binding Nature of Assignment. This Agreement shall be
binding upon and inure to the benefit of the
successors and permitted assigns of the Parties. Any
assignment not in accordance with this Section 9.3
shall be void.
9.4 No Waiver. The failure of either Party to require performance
by the other Party of any of that other Party's obligations hereunder shall in
no manner affect the right of such Party to enforce the same at a later time. No
waiver by any Party hereto of any condition, or of the breach of any provision,
term, representation or warranty contained in this Agreement, whether by conduct
or otherwise, in any one or more instances, shall be deemed to be or construed
as a further or continuing waiver of any such condition or breach, or of any
other condition or of the breach of any other provision, term, representation or
warranty hereof.
9.5 Severability. If a court or other tribunal of competent
jurisdiction should hold any term or provision of this Agreement to be
excessive, or invalid, void or unenforceable, the offending term or provision
shall be deleted or revised to the extent necessary to be enforceable,
-17-
and, if possible, replaced by a term or provision which, so far as practicable
achieves the legitimate aims of the Parties.
9.6 Relationship between the Parties. Both Parties are independent
contractors under this Agreement. Nothing herein contained shall be deemed to
create an employment, agency, joint venture or partnership relationship between
the Parties hereto or any of their agents or employees, or any other legal
arrangement that would impose liability upon one Party for the act or failure to
act of the other Party. Neither Party shall have any express or implied power to
enter into any contracts or commitments or to incur any liabilities in the name
of, or on behalf of, the other Party, or to bind the other Party in any respect
whatsoever.
9.7 Correspondence and Notices.
9.7.1 Ordinary Notices. Correspondence, reports,
documentation, and any other communication in writing between the Parties in the
course of ordinary implementation of this Agreement shall be delivered by hand,
sent by facsimile, overnight courier or by airmail to the employee or
representative of the other Party who is designated by such other Party to
receive such written communication.
9.7.2 Extraordinary Notices. Extraordinary notices and
communications (including, without limitation, notices of termination, force
majeure, material breach, change of address, claims or indemnification) shall be
in writing and sent to each Party by prepaid registered or certified air mail,
or by facsimile confirmed by prepaid registered or certified air mail letter
(and shall be deemed to have been properly served to the addressee upon receipt
of such written communication) to the address set forth in Section 9.7.3 or such
other address as notified in writing by such Party to the Other Party.
9.7.3 Addresses. In the case of Buyer, the proper address
for communications and for all payments shall be:
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Attn: Chief Executive Officer and President
Fax: 000-000-0000
with a copy to:
Xxxxxx & Xxxxxxx
00000 Xxxx Xxxxx Xxxxx
Xxxxx 000
Xxx Xxxxx, XX 00000
Attention: Xxxxx X. Xxxxx
Telecopier No. 000-000-0000
-18-
and it the case of Wyeth, the proper address for communications and for all
payments shall be:
Wyeth-Ayerst Laboratories
000 Xxxx Xxxxxxxxx Xxxxxx
Xx. Xxxxxx, Xxxxxxxxxxxx 00000
Attn: Senior Vice President, Global Business Development
Fax: (000) 000-0000
with a copies to:
American Home Products Corporation
0 Xxxxxxx Xxxxx
Xxxxxxx, Xxx Xxxxxx 00000
Attn: Executive Vice President and General Counsel
Fax: (000) 000-0000
Communications Only:
Wyeth-Ayerst Pharmaceuticals
0000 Xxxxxxxxxxx Xxxx.
Xxxx xx Xxxxxxx, XX 00000
Attn: Assistant Vice President - U.S. Operations
Fax: (000) 000-0000
9.8 Choice of Law. This Agreement is subject to and governed by
the laws of the State of New York, excluding its conflict of law provisions.
9.9 Entire Agreement; Amendment. This Agreement, together with the
Asset Purchase Agreement, the Pharmaceutical Quality Agreement, the Senior Note
and the Security Agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings contained herein and
therein sets forth the complete, final and exclusive agreement between the
Parties with respect to the subject matter hereof and supersedes and terminates
all prior and contemporaneous agreements and understandings between the Parties,
whether oral or in writing. There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties other than as are set forth in this Agreement, the
Asset Purchase Agreement, the Pharmaceutical Quality Agreement, the Senior Note
and the Security Agreement. No subsequent alteration, amendment, change, waiver
or addition to this Agreement shall be binding upon the Parties unless reduced
to writing and signed by an authorized officer of each Party. No understanding,
agreement, representation or promise, not explicitly set forth herein, has been
relied on by either Party in deciding to execute this Agreement.
9.10 Headings. The headings and captions used in this Agreement are
solely for the convenience of reference and shall not affect its interpretation.
-19-
9.11 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be an original and all of which shall
constitute together the same document.
9.12 Further Actions. Each Party agrees to, in good faith, execute,
acknowledge and deliver such further instruments, and to do all other acts, as
may be necessary or appropriate in order to carry out the purposes and intent of
this Agreement including, without limitation, any filings with any antitrust
agency which may be required.
-20-
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as
of the date first above written.
AMERICAN HOME PRODUCTS CORPORATION
Acting through its Wyeth-Ayerst
Laboratories Division
By: /s/ XXXXXXX X. XXXXXXX
-------------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Vice President and
Associate General Counsel
WOMEN FIRST HEALTHCARE, INC.
By: /s/ XXXXXX X. XXXXXX
-------------------------------------
Name: Xxxxxx X. Xxxxxx
Title: Chairman, Chief Executive
Officer and President
-21-
EXHIBIT A
------------------------------------------------------------------------------------
NDC Description Package Size
--- ----------- ------------
------------------------------------------------------------------------------------
009102 Equagesic(R)Tablets Bottle of 100
(meprobamate 200 mg, aspirin 325 mg)
------------------------------------------------------------------------------------
419101 Synalgos(R)DC Capsules Bottle of 100
(16 mg drocode bitartrate, 356.4 mg aspirin and 30 mg
caffeine)
------------------------------------------------------------------------------------
419102 Synalgos(R)DC Capsules Bottle of 500
(16 mg drocode bitartrate, 356.4 mg aspirin and 30 mg
caffeine)
------------------------------------------------------------------------------------
--------------------------------------------------------------------------------
NDC Description Initial Transfer Price
--- ----------- ----------------------
009102 Equagesic(R)Tablets Bottle of 100 ***
419101 Synalgos(R)DC Tablets Bottle of 100 ***
419102 Synalgos(R)DC Tablets Bottle of 500 ***
--------------------------------------------------------------------------------
--------------------------------------------------------------------------------
NDC Description 2002 Transfer Price
--- ----------- -------------------
009102 Equagesic(R)Tablets Bottle of 100 ***
419101 Synalgos(R)DC Tablets Bottle of 100 ***
419102 Synalgos(R)DC Tablets Bottle of 500 ***
--------------------------------------------------------------------------------
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-22-
EXHIBIT B
[Insert Pharmaceutical Quality Agreement]
-23-
EXHIBIT C
ADVERSE DRUG EXPERIENCE REPORTING REQUIREMENTS
----------------------------------------------
This is to advise Wyeth and Buyer (separately, a "Party" and collectively, the
"Parties") of the data exchange between themselves regarding adverse drug
experiences related to the use of Drug Products which will be marketed in
accordance with this agreement. The Parties seek to ensure that in the worldwide
marketing of pharmaceutical products they adhere to the highest ethical
standards and act in conformity with the laws under which they operate. This in
turn assures the Parties' licensees, distributors and customers of the quality
of their products.
It is a requirement of the U.S. Food and Drug Administration ("FDA") that the
Parties record, investigate, summarize and review all adverse drug experiences
associated with the Products. The Parties agree to adhere to requirements of
local laws, which relate to the reporting and investigation of adverse drug
experiences. To achieve the goal of accurate and timely reporting, the Parties
wish to systematize their processes.
Therefore, the Parties are required to exchange information in accordance with
the guidelines set forth in this Exhibit C.
Table A
-------------------------------------------------------------------------------------------------------------------------------
Investigational New Drugs
Marketed Drugs (Pre-marketing)
-------------------------------------------------------------------------------------------------------------------------------
Adverse Drug Experience Any adverse event associated with the use of a See Marketed Drugs
("ADE") drug in humans, whether or not considered
drug related, including:
o an adverse event occurring in
the course of the use of a
drug product in professional
practice;
o an adverse event occurring
from drug overdose, whether
accidental or intentional;
o an adverse event occurring
from drug withdrawal; and any
failure of expected
pharmacological action
-------------------------------------------------------------------------------------------------------------------------------
Disability A substantial disruption of a person's ability See Marketed Drugs
to conduct normal life functions
-------------------------------------------------------------------------------------------------------------------------------
Life-threatening adverse Any adverse drug experience that places that See Marketed Drugs
drug experience patient, in the view of the initial reporter, at
at immediate risk of death from the adverse drug
-------------------------------------------------------------------------------------------------------------------------------
-24-
Table A
-------------------------------------------------------------------------------------------------------------------------------
Investigational New Drugs
Marketed Drugs (Pre-marketing)
-------------------------------------------------------------------------------------------------------------------------------
experience as it occurred (i.e. it does not
include an adverse drug experience that, had it
occurred in a more serious form, might have
caused death)
-------------------------------------------------------------------------------------------------------------------------------
Associated with the use of There is a reasonable possibility that the There is a reasonable possibility that the
the drug experience may have been caused by the drug. experience may have been caused by the drug.
(For studies with marketed drug)
-------------------------------------------------------------------------------------------------------------------------------
Serious adverse drug Any adverse drug experience occurring at any See Marketed Drugs
experience dose that results in any of the following
outcomes:
o death,
o a life-threatening adverse
experience,
o inpatient hospitalization or
prolongation of existing
hospitalization,
o a persistent or significant
disability/incapacity, or
o a congenital anomaly/birth
defect.
Important medical events that may not result
in death, be life-threatening, or require
hospitalization may be considered a serious
adverse drug experience when, based upon
appropriate medical judgment, they may
jeopardize the patient or subject and may
require medical or surgical intervention to
prevent one of the outcomes listed in this
definition. Examples of such medical events
include allergic bronchospasm requiring
intensive treatment in an emergency room
or at home, blood dyscrasias or convulsions
that do not result in inpatient hospitalization,
or the development of drug dependency or abuse.
-------------------------------------------------------------------------------------------------------------------------------
Unexpected adverse drug Any adverse drug experience that is not Any adverse drug experience, the specificity
experience listed in the current labeling for the drug or severity of which is not consistent with
product. This includes events that may be the current investigator brochure; or, if an
symptomatically and pathophysiologically investigator brochure is not required or
related to an event listed in the labeling, available, the specificity or severity of
but differs from the event because of greater which is not consistent with the risk
severity or specificity. For example, under information described in the general
this definition, hepatic necrosis would be investigational plan or elsewhere in the
unexpected (by virtue of greater severity) if current application, as amended. For
the labeling only referred to elevated example, under this definition, hepatic
hepatic enzymes or hepatitis. Similarly, necrosis would be unexpected (by virtue of
cerebral thromboembolism and cerebral greater severity) if the investigator
vasculitis brochure
-------------------------------------------------------------------------------------------------------------------------------
-25-
Table A
-------------------------------------------------------------------------------------------------------------------------------
Investigational New Drugs
Marketed Drugs (Pre-marketing)
-------------------------------------------------------------------------------------------------------------------------------
would be unexpected (by virtue of referred to elevated hepatic enzymes or
greater specificity) if the labeling only hepatitis. Similarly, cerebral
listed cerebral vascular accidents. thromboembolism and cerebral vasculitis
"Unexpected" refers to an adverse drug would be unexpected (by virtue of greater
experience that has not been previously specificity) if the investigator brochure
observed (i.e., included in the labeling) only listed cerebral vascular accidents.
rather than from the perspective of such "Unexpected" refers to an adverse drug
experience not being anticipated from the experience that has not been previously
pharmacological properties of the observed (i.e., included in the investigator
pharmaceutical product. brochure) rather than from the perspective
of such experience not being anticipated
from the pharmacological properties of the
pharmaceutical product.
-------------------------------------------------------------------------------------------------------------------------------
ADE(s) are required to be reported as follows:
1. All ADE(s) source documents received by Wyeth will be forwarded to Buyer
within 24 hours of Wyeth's Global Safety Surveillance and Epidemiology
Department (GSSE) receipt date. Buyer will be solely responsible for ADE
reporting to the FDA.
Reports to Buyer are to be transmitted as follows:
Xxxxxxx Xxxxx
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, Xxxxxxxxxx 00000
Tel. (000) 000-0000
Fax (000) 000-0000
2. Wyeth will produce the U.S. Periodic for the Product(s) in accordance with
the Code of Federal Regulations capturing the time period from the last day
of the previous reporting period up until the date of closing, and will
forward to the FDA. Wyeth will promptly provide Buyer with a copy of the
U.S. Periodic report upon submission to the FDA. Buyer will be responsible
for the U.S. Periodic report after closing; it being understood that Wyeth
shall promptly provide Buyer any subsequent relevant data in its possession
to assist Buyer in the preparation of such report.
3. Wyeth shall provide Buyer with the U.S. Periodic Report (prepared in
accordance with the Code of Federal Regulations) for the Product capturing
the time period during which Wyeth owned the Product. Buyer shall use the
data contained in that Report and any subsequent relevant data provided by
Wyeth (which data Wyeth agrees to promptly provide to Buyer) to, in part,
produce, when due, the first U.S. Periodic Report required to be filed with
the FDA after Closing. After Closing, Wyeth shall not submit any U.S.
Periodic Reports with respect to the Products.
4. Wyeth shall provide Buyer with copies of historical written documents,
correspondence, reports and any other written information in the possession
or control of Wyeth related to the safety of the Product for the last five
(5) years and, if requested by Buyer, for previous years as well.
-26-
Schedule I
***
*** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
-27-