EXHIBIT 10.2
EXECUTION COPY
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.
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SUPPLY AGREEMENT
Between
XXXXXXX-XXXXX SQUIBB COMPANY
and
WOMEN FIRST HEALTHCARE, INC.
for
VANIQA(R)
Dated as of June 25, 2002
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TABLE OF CONTENTS
-----------------
SECTION 1. DEFINITIONS ................................................................... 1
Section 1.01. Definitions ........................................................... 1
Section 1.02. Other Definitions ..................................................... 4
Section 1.03. Interpretations. ...................................................... 5
SECTION 2. GENERAL TERMS OF SUPPLY ....................................................... 5
Section 2.01. Sale and Purchase of Product .......................................... 5
Section 2.02. Forecasts ............................................................. 6
Section 2.03. Ordering .............................................................. 6
Section 2.04. Shipments ............................................................. 7
Section 2.05. Receipt of Product .................................................... 8
Section 2.06. Quality Control; Change in Specifications or Supplier ................. 9
Section 2.07. Material Safety Data Sheets ........................................... 11
Section 2.08. BMS Supply Contracts .................................................. 11
Section 2.09. Line Extension Product and New Product ................................ 11
Section 2.10. Maintenance of Manufacturing Facility Registrations ................... 12
Section 2.11. Maintenance of Product Registrations .................................. 12
Section 2.12. Promotional and Advertising Materials ................................. 13
Section 2.13. Intellectual Property; License Grant. ................................. 13
SECTION 3. PURCHASE PRICE FOR PRODUCT .................................................... 14
Section 3.01. Purchase Price ........................................................ 14
SECTION 4. PAYMENTS AND REPORTS .......................................................... 15
Section 4.01. Payment; Books and Records ............................................ 15
Section 4.02. Mode of Payment ....................................................... 15
Section 4.03. Taxes ................................................................. 16
Section 4.04. Late Payments ......................................................... 16
SECTION 5. COMPLIANCE WITH LAWS; REPRESENTATIONS AND WARRANTIES .......................... 16
Section 5.01. Compliance with Law; Cooperation ...................................... 16
Section 5.02. BMS Representations, Warranties and Covenants ......................... 17
Section 5.03. The Company Representations, Warranties and Covenants ................. 18
Section 5.04. Representations and Warranties of Each Party .......................... 18
Section 5.05. Disclaimer of Warranties .............................................. 19
Section 5.06. No Reliance by Third Parties .......................................... 19
SECTION 6. INDEMNIFICATION; REMEDIES FOR BREACH .......................................... 19
Section 6.01. BMS Indemnity ......................................................... 19
Section 6.02. The Company Indemnity ................................................. 19
Section 6.03. Limitations on Liability and Remedies ................................. 20
Section 6.04. Control of Proceedings ................................................ 20
(i)
TABLE OF CONTENTS (continued)
----------------------------
Section 6.05. Insurance ............................................................ 21
Section 6.06. Other Limitations on Liability ....................................... 21
Section 6.07. Calculation of Losses ................................................ 21
SECTION 7. COMPLIANCE WITH GOVERNMENT REGULATIONS ........................................ 22
Section 7.01. Government Communications ............................................ 22
Section 7.02. Access to Records .................................................... 22
Section 7.03. Governmental and Regulatory Inspections .............................. 22
Section 7.04. The Company Inspections .............................................. 22
Section 7.05. Regulatory Matters. .................................................. 23
SECTION 8. STABILITY; PRODUCT RECALLS; ADVERSE EXPERIENCES;
PRODUCT QUALITY COMPLAINTS; AND MEDICAL INQUIRIES ............................. 24
Section 8.01. Stability ............................................................ 24
Section 8.02. Product Recalls ...................................................... 24
Section 8.03. Adverse Experience ................................................... 25
Section 8.04. Product Quality Complaints ........................................... 26
Section 8.05. Medical Inquiries .................................................... 27
Section 8.06. Disclosure Information ............................................... 28
SECTION 9. CONFIDENTIALITY ............................................................... 28
Section 9.01. Confidentiality Requirement .......................................... 28
Section 9.02. Use of Information ................................................... 29
Section 9.03. Acquired Assets ...................................................... 29
Section 9.04. Relief ............................................................... 29
SECTION 10. TERMINATION ................................................................... 30
Section 10.01. Term ................................................................. 30
Section 10.02. Breach ............................................................... 30
Section 10.03. Bankruptcy ........................................................... 30
Section 10.04. Effect of Termination ................................................ 30
Section 10.05. Accrued Rights, Surviving Obligations ................................ 31
SECTION 11. FORCE MAJEURE ................................................................. 31
SECTION 12. TECHNICAL ASSISTANCE .......................................................... 32
Section 12.01. Technical Assistance ................................................. 32
SECTION 13. NOTICES ....................................................................... 33
SECTION 14. MISCELLANEOUS PROVISIONS ...................................................... 34
Section 14.01. Assignment ........................................................... 34
Section 14.02. Non-Waiver ........................................................... 34
Section 14.03. Dispute Resolution ................................................... 34
(ii)
Section 14.04. Entire Agreement ..................................................... 35
Section 14.05. Public Announcements ................................................. 35
Section 14.06. Governing Law ........................................................ 35
Section 14.07. Relationship of the Parties .......................................... 35
Section 14.08. Counterparts ......................................................... 36
Section 14.09. Severability ......................................................... 36
Section 14.10. Expenses ............................................................. 36
Section 14.11. Descriptive Headings ................................................. 36
Section 14.12. Amendments and Waivers ............................................... 36
Section 14.13. Specific Performance ................................................. 36
Section 14.14. Successors and Assigns ............................................... 37
Section 14.15. Waiver of Jury Trial ................................................. 37
SCHEDULES
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Schedule 1.01 Product Information
Schedule 2.03(a) Initial Firm Order for Months 1 to 6 after Effective Date
Schedule 2.04 Form of Certificate of Analysis
Schedule 3.01(a) Initial Purchase Price and Batch Size
Schedule 3.01(b) Variable Product Costs
(iii)
THIS SUPPLY AGREEMENT (this "Agreement") dated as of June 25, 2002 (the
"Effective Date"), is between Xxxxxxx-Xxxxx Squibb Company, a Delaware
corporation ("BMS"), and Women First HealthCare, Inc., a Delaware corporation
(the "Company").
RECITALS
WHEREAS, BMS and Xxx Xxxxxxxx Xxxxxxx ("Xxxxxxxx"), through their
respective wholly-owned subsidiaries, entered into a Delaware general
partnership on October 7, 1996 to form Westwood-Squibb Colton Holdings
Partnership (the "Partnership") for purposes of manufacturing, distributing,
marketing and selling the Product (as defined below);
WHEREAS, the Company, the Partnership, BMS and Xxxxxxxx entered into an
Asset Purchase Agreement, dated as of June 25, 2002 (the "Asset Purchase
Agreement"), pursuant to which the Partnership will sell to the Company, and the
Company will purchase from the Partnership, on the Effective Date, certain
rights, title and interest in and to the Product; and
WHEREAS, the Company wishes to purchase from BMS, and BMS wishes to supply
to the Company, the Company's entire worldwide requirements of the Product,
pursuant to the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the premises and the mutual covenants
and promises contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties (as
defined below) hereby agree as follows:
SECTION 1.
DEFINITIONS
Section 1.01. Definitions.
For purposes of this Agreement:
"Acquired Assets" shall have the meaning set forth in the Asset Purchase
Agreement.
"Affiliate" means, with respect to any Person, any Person which, directly
or indirectly, controls, is controlled by, or is under common control with, the
specified Person. For the purposes of this definition, the term "control", as
applied to any Person, means the possession, directly or indirectly, of the
power to direct or cause the direction of the management of that Person, whether
through ownership of voting securities or otherwise.
"Agreement" means this agreement, together with all appendices, exhibits
and schedules hereto, and as the same may be amended or supplemented from time
to time.
"BMS Know-How" shall have the meaning set forth in the License Agreement.
"BMS Manufacturing Know-How" means the percentages and specification of
ingredients, the manufacturing processes, specifications, technology,
inventions, assays, quality control and testing procedures, Know-How and trade
secrets Controlled by BMS and used to manufacture, formulate, test, label or
package the Product as of the Effective Date but not used exclusively for the
Product.
"C.F.R." means the U.S. Code of Federal Regulations.
"Controlled by" shall have the meaning set forth in the License Agreement.
"EXW" means Ex Works as defined in the International Chamber of Commerce
Incoterms 2000.
"Facility" means any manufacturing facility(ies), whether located
within or outside the United States, that manufacture, finish, label or package
the Product pursuant to this Agreement.
"FDA" means the United States Food and Drug Administration, or any
successor entity.
"FD&C Act" means the United States Food, Drug and Cosmetics Act, as
amended.
"Firm Order" means a written irrevocable firm purchase order for the
Product, which order shall include a delivery schedule specifying the requested
delivery date and quantity of the Product ordered, and the location to which
shipment of the Product is to be delivered.
"Fully-Burdened Cost" means: (a) in connection with the manufacture,
labeling and packaging of the Product, the cost of materials, labor and variable
overhead incurred in manufacturing plus the fully absorbed allocation of fixed
overhead (including without limitation a reasonable allocation of idle plant
charges), in each case with respect to the Facility at which such Product is
manufactured; and (b) in connection with the performance or provision of a
service, the direct and indirect costs incurred by a Party to perform or provide
the service (including without limitation reasonable overhead charges),
determined in accordance with GAAP; in each case as evidenced by reasonably
detailed supporting documentation and prepared consistently from period to
period.
"GAAP" means United States generally accepted accounting principles
consistently applied.
"Xxxxxxxx Know-How" shall have the meaning set forth in the License
Agreement.
"Good Manufacturing Practices" or "cGMP" means current good manufacturing
practices, as established by the FDA and all other applicable Laws, as may be
amended from time to time.
"Governmental Entity" means any court of competent jurisdiction,
legislature, governmental agency, administrative agency, regulatory agency or
commission or other governmental authority or other instrumentality of the
United States or any other country, any state, county, city or other political
subdivision (including the FDA and the corresponding authorities in the
jurisdictions where the Product is marketed, distributed or sold).
"Improvement" means any modification by the Purchaser or its Affiliates to
the Product, including, without limitation, any modification in its manufacture,
composition, preparation, means of delivery or dosage but shall specifically
exclude (a) any such modification by Xxxxxxxx, BMS or any of their respective
Affiliates and (b) any modification to the Product that alters or substitutes
the Product's active ingredient.
"Inventory" shall have the meaning set forth in the Asset Purchase
Agreement.
"Laws" means all laws, rules, regulations, ordinances and other
requirements of any Governmental Entity.
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"License Agreement" means the License Agreement, dated as of the Effective
Date, among the Company, BMS and Xxxxxxxx.
"Losses" means losses, liabilities, claims, damages and expenses
(including, until such time as the indemnifying Party has notified the
indemnified Party in writing that it will assume control of a given claim,
reasonable attorneys fees and costs of litigation pertaining to such claim), and
expenses paid or payable by an indemnified party to a Third Party.
"MAA" or "Marketing Approval Application" means a NDA or a Premarket
Approval Application, as required under the FD&C Act and the regulations
promulgated thereunder, or a comparable filing for marketing approval in a
country.
"Manufacturing Facility Registrations" means the approvals, permits,
applications, licenses or registrations granted by the relevant Governmental
Entity to a Facility for the manufacture of the Product or any other products at
such Facility. For sake of clarity, Manufacturing Facility Registrations do not
include Product Registrations.
"Material Safety Data Sheet" means the material safety data sheet used to
comply with the Occupational Safety and Health Administration's Hazard
Communication Standard, 29 C.F.R. 1910.1200.
"NDA" means any new drug application filed pursuant to the requirements of
the FDA, as more fully defined in 21 C.F.R. Part 314.5 et seq., and any
equivalent application filed with any Governmental Entity.
"NDC" means the unique, identifying number assigned to a drug product,
including the labeler code, product code and package code, in connection with
the drug listing requirements of Section 510(j) of the FD&C Act and applicable
FDA rules and regulations.
"Partnership Manufacturing Know-How" means the percentages and
specifications of ingredients, the manufacturing processes, specifications,
technology, inventions, assays, quality control and testing procedures, Know-How
and trade secrets Controlled by the Partnership and used exclusively to
manufacture, formulate, test, label or package the Product as of the Effective
Date.
"Party" means BMS or the Company and, when used in the plural, means BMS
and the Company.
"Person" means any individual, group, corporation, partnership or other
organization or entity (including any Government Entity).
"Prime Rate" means the rate of interest from time to time announced as the
prime commercial lending rate to the most creditworthy customers by a bank of
national standing agreed to by the Parties.
"Product" means the prescription form of VANIQA(R) (eflornithine
hydrochloride) Cream, 13.9% and further listed and described on Schedule 1.01,
as the same is manufactured, packaged and labeled in accordance with applicable
Laws and the applicable Product Registration and Specifications, including all
strengths and packaging configurations of the final finished dosage form
presentation existing on the Effective Date.
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"Product Registrations" means the approvals, permits, applications,
licenses or registrations (including but not limited to the NDA) and any
amendments or supplements thereto for the Product which have been received in
order to market or sell same (and related submissions to and correspondence with
the relevant Governmental Entity). For the avoidance of doubt, the Parties agree
that Product Registrations do not include any Manufacturing Facility
Registration, any NDC number or any drug listing required by 21 C.F.R. Part 207.
"Related Instruments" means the Asset Purchase Agreement, the License
Agreement and any other written agreements contemplated thereunder to which the
Parties are parties.
"Specifications" for the Product means the written specifications set forth
in the applicable NDA as of the Closing Date (as defined in the Asset Purchase
Agreement), as the same may be amended or supplemented from time to time
hereafter by the Company in accordance with Section 2.06(b).
"Third Party" means any Person who or which is neither a Party nor an
Affiliate of a Party.
"United States" and "U.S." means the fifty (50) states of the United States
of America and the District of Columbia, Puerto Rico and any other territory or
possession of the United States.
Section 1.02. Other Definitions.
The following terms have the meanings set forth in the Sections set forth
below:
Term Section
---- -------
Asset Purchase Agreement Recitals
Audit 7.04
BMS Preamble
BMS Party 6.02
Company Preamble
Company Party 6.01
Confidential Information 9.01(a)
Effective Date Preamble
Facility Audit 5.01(c)
Facility Technical Information 2.10(b)
Force Majeure Event 11
Forecast 2.02
Xxxxxxxx Recitals
Non-Serious Adverse Event 8.03(b)
Partnership Recitals
PDMA 2.12
Product Quality Complaint 8.04(a)
Purchase Price 3.01(a)
Recall 8.02
Retained Rights 2.14
Serious Adverse Event 8.03(b)
SKU 2.02
Stability Study 8.01(b)
Technical Information 2.11(b)
Term 10.01
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Any other terms capitalized in this Agreement and not defined in Section 1.01 or
referenced in this Section 1.02 shall have the meaning ascribed to such term in
the Asset Purchase Agreement for the Product.
Section 1.03. Interpretations.
(a) In the event an ambiguity or a question of intent or
interpretation arises, this Agreement shall be construed as if drafted jointly
by the Parties and no presumption or burden of proof shall arise favoring or
disfavoring any Party by virtue of the authorship of any provisions of this
Agreement.
(b) The definitions of the terms herein shall apply equally to the
singular and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms. The words "include", "includes" and "including" shall be deemed to
be followed by the phrase "without limitation". The word "will" shall be
construed to have the same meaning and effect as the word "shall". Unless the
context requires otherwise; (A) any definition of or reference to any agreement,
instrument or other document herein shall be construed as referring to such
agreement, instrument or other document or any addenda, schedules, exhibits or
amendments thereto, and as from time to time amended, supplemented or otherwise
modified (subject to any restrictions on such amendments, supplements or
modifications set forth herein or therein); (B) any reference to any Laws herein
shall be construed as referring to such Laws as from time to time enacted,
repealed or amended; (C) any reference herein to any Person shall be construed
to include the Person's successors and assigns; (D) the words "herein", "hereof"
and "hereunder", and words of similar import, shall be construed to refer to
this Agreement in its entirety and not to any particular provision hereof; (E)
all references herein to Sections, Exhibits or Schedules shall be construed to
refer to Sections, Exhibits and Schedules of this Agreement; and (F) the
singular number includes the plural number and vice versa.
SECTION 2.
GENERAL TERMS OF SUPPLY
Section 2.01. Sale and Purchase of Product.
(a) BMS (either itself or through its Affiliates) shall supply to the
Company, and the Company shall, subject to the terms and conditions of this
Agreement, purchase from BMS, one hundred percent (100%) of the Company's
requirements for the Product for marketing, distribution, sale and use during
the Term, pursuant to Firm Orders submitted by the Company to BMS from time to
time in accordance with Section 2.03, at the Purchase Price, and subject to
Section 5.02.
(b) All quantities of the Product shall be supplied hereunder by BMS
in finished dosage form, filled, labeled, branded and packaged for commercial
sale or distribution, or as samples, as the case may be, in accordance with the
terms and conditions of this Agreement, the Specifications and applicable Laws.
BMS shall solely and exclusively supply the Product to the Company, its
Affiliates and their respective designees. BMS shall be responsible for the
purchase of all raw materials for the manufacture of the Product in accordance
with the Product Registrations as necessary to supply the finished Product to
the Company under this Agreement.
(c) BMS and the Company shall take any and all actions necessary to
change, as expeditiously as possible, the NDC numbers for the Product and to
apply new NDC numbers to the
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Product. For no more than six (6) months following the Effective Date, the
Product manufactured hereunder may continue to be labeled and packaged with the
same labels and packaging that are used by BMS in connection with its
manufacture of the Product for the Partnership as of the Effective Date;
provided, however, that the Parties shall use their commercially reasonable
efforts to complete the revision of all Product labeling and packaging sooner.
After such time, the Product shall be manufactured with labeling, branding,
trade dress and packaging identifying BMS or any Affiliate thereof as the
manufacturer of the Product and the Company (or the Company's designee) as the
distributor thereof and the labeling shall reflect the Company's NDC number.
Promptly after the Effective Date, BMS shall provide to the Company samples and
copies of all labeling, branding, trade dress and packaging for the Product as
of the Effective Date. Within sixty (60) calendar days following the delivery by
BMS to the Company of the current labeling and packaging, the Company shall
provide to BMS final specifications for the revised labeling, branding, trade
dress and packaging of the Product, including all necessary photo-ready art (or
its substantial equivalent) reflecting such revisions.
(d) Subject to the provisions of Section 2.01(c), the Company shall
control and shall have sole responsibility for, the content and type of all
labeling and packaging (and any changes or supplements thereto) for the Product.
Except as otherwise provided in the Asset Purchase Agreement, all such
activities related to any changes or supplements to the labeling and packaging
shall be conducted at the Company's sole cost and expense, including any
Fully-Burdened Costs incurred by BMS plus 15% in securing any approvals required
by the FDA or other applicable regulatory authorities for any such changes or
supplements, excluding the cost of any printed materials or label inventory that
cannot be used following the change. BMS shall be responsible for obtaining such
labels in accordance with the content specified by the Company. Any changes to
the labeling and packaging shall be communicated to BMS in writing at least one
hundred twenty (120) calendar days (or, if shorter, the period required by
applicable Laws or Government Entities) prior to the desired implementation date
together with the documentation specifying the content to be included in the
labeling and packaging, including all necessary photo-ready art (or its
substantial equivalent). BMS shall not be required to implement such changes
until its first batch run after the expiration of such one hundred twenty (120)
day (or shorter) period. However, BMS shall endeavor to implement the changes as
early as practicable.
(e) No terms and conditions contained in any Firm Order,
acknowledgment, invoice, xxxx of lading, acceptance or other preprinted form
issued by either Party shall be effective to the extent they are inconsistent
with or modify the terms and conditions contained herein.
Section 2.02. Forecasts.
The Company shall submit to BMS upon execution of this Agreement and
thereafter no later than thirty (30) days before the first day of every calendar
quarter (i.e., January 1, April 1, July 1, and October 1) during the Term
hereof, a twenty-four (24) month rolling forecast ("Forecast") organized by
months and Product stock keeping units ("SKUs") setting forth orders the Company
expects to place for the Product during such period commencing with the
beginning of said calendar quarter. The Company shall make all Forecasts in good
faith given market and other information available to the Company. All Forecasts
are non-binding except as set forth in Section 2.03 below.
Section 2.03. Ordering.
(a) Upon the execution of this Agreement, the Company will provide
BMS with its initial Firm Order of Product for its requirements through December
31, 2002, the quantities and delivery dates for such initial Firm Order shall be
attached as Schedule 2.03(a), and is in addition to the Inventory to be
delivered to the Company pursuant to the Asset Purchase Agreement. BMS will
supply the
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quantities set forth in Schedule 2.03(a) for the Product in accordance with the
delivery schedule set forth therein (it being understood that BMS shall be under
no obligation to deliver in excess of [***] units of the Product ordered
pursuant to this Section 2.03(a) sooner than sixty (60) days after the Effective
Date of this Agreement), and to the extent such initial Firm Order is not
sufficient to meet the Company's actual requirements for the Product for such
period, BMS will use its commercially reasonable efforts to supply the Company
with its requirements beyond the amounts specified in Schedule 2.03(a). The
Company agrees to purchase such quantities of the Product as supplied by BMS in
accordance with Schedule 2.03(a).
(b) Except as provided in Section 2.03(a), and subject to the terms
and conditions of this Agreement, the Company shall purchase the Product solely
by Firm Orders for the Product. The terms and conditions of this Agreement shall
be controlling over any conflicting terms and conditions in such Firm Order. The
Company shall submit each such written Firm Order to BMS at least one hundred
twenty (120) days in advance of the date specified in each Firm Order on which
delivery of the Product is required. Each such Firm Order shall be binding on
the Company and on BMS once such Firm Order is accepted by BMS (it being
understood that such Firm Order shall be deemed to be accepted by BMS if it
meets the requirements as set forth in this Agreement). Prior to the placement
of Firm Orders, the Parties shall communicate regarding BMS' production
schedules for the Product and the Company's anticipated delivery requirements
for the Product so that the Parties can coordinate BMS's production schedules
and the Company's delivery requirements to enable BMS to supply Product to the
Company with the maximum practicable shelf life at the time of shipment.
Notwithstanding the foregoing, BMS shall attempt to accommodate any request of
the Company for delivery of the Product in less than one hundred twenty (120)
days, and further, BMS will attempt to accommodate any changes requested by the
Company in delivery schedules for the Product following BMS' receipt of Firm
Orders from the Company; provided, however, BMS shall not be liable for any
failure or inability to do so. Subject to the foregoing, upon receipt of each
Firm Order by BMS hereunder, BMS shall supply the Product in such quantities
(with any variances permitted hereunder) and deliver the Product to the Company
on the requested delivery dates specified in such Firm Order, unless otherwise
mutually agreed in writing by the Parties. To the extent that such Firm Order is
not sufficient to meet the Company's actual requirements, BMS shall use
commercially reasonable efforts to supply the Company with its requirements
beyond the amounts specified in its Firm Order; provided, however, BMS shall not
be liable for any failure or inability to do so. BMS is not entitled to accept
verbal orders of any kind for the production of the Product hereunder.
(c) Quantities of the Product actually shipped by BMS may vary from
the quantities specified in any Firm Order by plus or minus ten percent (10%),
or as mutually agreed upon by the Parties, and still be deemed to be in
compliance with such Firm Order; provided, however, the Company only shall be
invoiced and required to pay for the quantities that BMS actually ships to the
Company.
(d) Any Product ordered by the Company for delivery on each specified
delivery date shall be consistent with BMS' current minimum batch sizes for the
Product, or multiples thereof, as set forth in Schedule 3.01(a). BMS may change
the batch size at any time; provided that BMS gives the Company no less than six
months prior notice; and provided further that such changes in batch size
conform with Product Registrations and applicable Laws.
Section 2.04. Shipments.
BMS shall ship each Firm Order, EXW Facility for the Product (whether
manufactured by BMS, an Affiliate of BMS or a Third Party) to the Company or its
designee to the destinations specified by the Company on the applicable Firm
Order using the Company's designated common carrier.
***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.
-7-
Freight (including customs clearance costs) and insurance shall be for the
account of the Company. Title shall pass to the Company and the risk of loss,
delay or damage in transit shall be with the Company, from and after the
Company's designated common carrier takes custody of the Product from BMS at the
Facility (including, without limitation any loss from an environmental impact
arising from the release or consumption of the Product); provided, however, that
such transfer of title and risk of loss, delay and damage shall not in any way
otherwise obviate or limit the representations and warranties or indemnification
obligations of BMS hereunder. BMS shall package the Product for shipment in
accordance with appropriate packaging and shipping containers agreed upon by the
Parties, unless otherwise specified in writing by the Company sixty (60)
business days prior to such shipment, in which event any extra costs incurred by
BMS on account of the packaging changes requested by the Company shall be
promptly reimbursed by the Company. In the event that BMS receives less than
sixty (60) business days notice of a request for alternate packaging, BMS shall
not be required to repackage any shipments that have already been packed for
shipment. BMS shall include the following with each shipment of the Product: (a)
the Company purchase order number; (b) the BMS lot and batch numbers for the
Product included; (c) the quantity of the Product; and (d) the Certificate of
Analysis (the form of which is attached hereto as Schedule 2.04).
Section 2.05. Receipt of Product.
(a) The Company shall be entitled to reject any portion or all of any
shipment of the Product that does not conform to the Specifications or otherwise
fails to comply in any material respect with Section 5.02(a) (unless such
non-conformity was attributable to an act or omission of the Company or the
common carrier once such Product, packaged for shipment in accordance with
Section 2.04, was accepted by such common carrier from BMS), provided, that, (i)
the Company shall notify BMS within thirty (30) calendar days after receipt of
such shipment if it is rejecting a shipment due to obvious physical damage or
quantity discrepancies that are evident upon visual inspection of the packaged
Product as shipped by BMS (unless caused by the common carrier or the Company),
(ii) except as otherwise provided in Section 2.05(a)(iii), the Company shall
notify BMS within ninety (90) calendar days after receipt of such shipment if it
is rejecting a shipment due to any defects other than those obvious visual
defects, and (iii) the Company shall notify BMS within ninety (90) calendar days
after the Company becomes aware of any defects in the case of Product having
defects that are attributable solely to BMS's manufacture of such Product.
Notwithstanding anything contained herein, the Company shall have no obligation
to inspect the Product beyond a visual inspection of each shipment for obvious
physical damage or quantity discrepancies that are evident upon visual
inspection of the packaged Product as shipped by BMS. Without in any way
limiting BMS' indemnity obligations as set forth in Section 6.01, if no notice
is provided by the Company within the relevant time periods set forth above,
then the Company shall be deemed to have accepted the shipment. Any notice of
rejection by the Company shall be accompanied by a reasonably detailed statement
of its reasons for rejection and a report of any pertinent analysis performed by
the Company on the allegedly non-conforming Product, together with the methods
and procedures used. BMS shall notify the Company as promptly and as reasonably
possible, but in any event within thirty (30) calendar days after receipt of
such notice of rejection, whether or not it accepts the Company's assertions of
non-conformity.
(b) Whether or not BMS accepts the Company's assertion of non-
conformity, promptly upon receipt of a notice of rejection, unless otherwise
specified by the Company, BMS shall use commercially reasonable efforts to
provide replacement Product for the Product that was rejected by the Company in
the original shipment within ninety (90) calendar days of receipt of the
Company's notice of non-conformity. If any such Product rejected by the Company
from such original shipment ultimately is found to be non-conforming (whether
pursuant to Section 2.05(c) or if BMS so acknowledges in writing), BMS shall
bear all expenses for such replacement Product (including all transportation
and/or disposal
-8-
charges and cost of manufacture for such non-conforming Product), to the extent
the Company previously paid for any corresponding non-conforming Product. If it
is determined subsequently that such non-conforming Product was in fact
conforming (whether pursuant to Section 2.05(c) or if the Company so
acknowledges in writing), then the Company shall be responsible not only for the
purchase price of the allegedly nonconforming Product (including all
transportation charges), but also, upon receipt and acceptance by the Company in
accordance with the procedures (and at the same price charged in the original
shipment) set forth above, the replacement Product. Replacement shipments shall
also be subject to the procedures contained in Section 2.05(a). BMS shall be
under no obligation to accept a return of Product except as provided in this
Section 2.05(b).
(c) If BMS disagrees with any alleged non-conformity with respect to
any Product it shall so notify the Company in writing with thirty (30) calendar
days of the Company's notice of non-conformity and BMS and the Company shall
promptly (and in no event longer than an additional thirty (30) calendar days)
cooperate with one another to retain an independent laboratory of recognized
repute, reasonably acceptable to both Parties, which shall analyze an aliquot
sample or such other portion of a shipment of such Product, furnished by the
Company from the shipment received by the Company, as may be necessary to
substantiate whether the shipment rejected by the Company conformed to the
Specifications or otherwise failed to comply in any material respect with
Section 5.02(a) at the time of delivery to the Company or its designee. The
laboratory shall use such procedures and tests as the laboratory may consider
necessary or appropriate to reach a conclusion. Both Parties agree to cooperate
with the independent laboratory's reasonable requests for assistance in
connection with its analysis hereunder. Both Parties shall be bound by the
laboratory's results of analysis, which, absent manifest error, shall be deemed
final as to any dispute over compliance of the Product with the Specifications
and/or compliance in any material respect with Section 5.02(a) at the time of
delivery to the Company or its designee. If the laboratory analysis shows that
the Product does not conform to the Specifications and/or that it does not
comply in all material respects with Section 5.02(a), the costs of such analysis
shall be paid by BMS. If the laboratory analysis shows that the Product does
conform to the Specifications and/or that it does comply in all material
respects with Section 5.02(a), the costs of such analysis shall be paid by the
Company.
(d) If BMS acknowledges an alleged non-conformity (or if the
laboratory concludes that the Product was non-conforming), BMS shall promptly
(and in any case within thirty (30) calendar days thereafter) make arrangements
for the return and disposal of the non-conforming Product. BMS shall pay, or
reimburse the Company, for the Fully-Burdened Costs incurred by the Company for
such return shipment of such non-conforming Product in accordance with BMS'
instructions.
Section 2.06. Quality Control; Change in Specifications or Supplier.
(a) BMS shall conduct all quality control testing of the Product prior
to shipment in accordance with the Product Registration and applicable Laws. BMS
shall retain records and samples of the Product relating to such testing as
required by applicable Law and shall provide the Company with reasonable access
during normal business hours to such records during any Audit in accordance with
the procedures set forth in Section 7.04; provided, however, that such access
does not unreasonably disrupt the normal operations of BMS. If the Company
conducts quality control testing of the Product after delivery thereof to the
Company, the Company shall use a laboratory qualified by BMS to ensure
consistency of testing with the BMS results. BMS shall promptly after the
Effective Date (and in no event later than thirty (30) days) provide all
analytical methodology used by BMS for quality control testing of the Product.
-9-
(b) The Company shall have the right: (i) subject to BMS' prior
written consent not to be unreasonably withheld, to change the Specifications
with respect to the Product from time to time; (ii) to change the Specifications
with respect to the Product without prior written consent, from time to time, as
may be required by any Governmental Entity having jurisdiction over the Product;
or (iii) to change the Specifications with respect to the Product by mutual
agreement of the Parties and in each case, on not less than one hundred twenty
(120) calendar days prior written notice to BMS (or such shorter period as
required by any Governmental Entity or mutually agreed by the Parties). In such
event, upon the reasonable request of the Company and at the Company's sole
expense, BMS shall assist with all analytical or experimental work to be
performed in connection with making such change, but the Company shall be
responsible, at the Company's expense, for filing all changes proposed by the
Company to any Product Registration, and for seeking approval of any such change
required by each applicable Governmental Entity. The Company shall reimburse BMS
or its Affiliates for its Fully-Burdened Costs incurred plus 15% in implementing
any changes to the Specifications in accordance with this Section 2.06(b)
requested by the Company in BMS' or its Affiliates' Facility, and for filing,
amending or supplementing any Manufacturing Facility Registration required
thereby and shall not hold BMS responsible for any reasonable disruption of
supply resulting from any such change in the Specifications.
(c) At any time and from time to time, BMS may, (i) in its sole
discretion, without the consent of the Company (but with sixty (60) days' prior
written notice) change the manufacturer or source of manufacturing used in the
manufacturing of the Product to an Affiliate of BMS, or to another BMS owned and
operated facility, provided that BMS shall remain responsible for all of its
obligations set forth herein, and provided further that any such change which
will result in a delay in BMS' or such other party's ability to meet the
Company's delivery requirements for Products pursuant to Firm Orders made
pursuant to Section 2.03 shall require the prior written consent of the Company
(not to be unreasonably withheld or delayed), (ii) with the Company's prior
written consent (not to be unreasonably withheld) change the manufacturer or
source of manufacturing used in the manufacturing of the Product to a Third
Party; provided that BMS shall be responsible for the acts or omissions of such
Third Party or (iii) without the consent of the Company (but with sixty (60)
days' prior written notice) change the manufacturer or manufacturing source used
in the manufacturing of the Product to a successor (whether by merger,
consolidation, reorganization or other similar event) or purchaser of the
Facility and/or substantially all of its business assets relating to the
Product, provided, that, such successor or purchaser has agreed in writing to
assume all of BMS' rights and obligations hereunder and a copy of such
assumption is provided to the Company, and provided further that any such change
which will result in a delay in BMS' or such other party's ability to meet the
Company's delivery requirements for Products pursuant to Firm Orders made
pursuant to Section 2.03 shall require the prior written consent of the Company
(not to be unreasonably withheld or delayed). The Company shall cooperate with
BMS (and such other manufacturer, if applicable) in any reasonable manner to
effect such transfer to an Affiliate of BMS, Third Party or successor. BMS shall
be responsible for making any required Manufacturing Facility Registration with
respect to such change in manufacturer and seeking approval from each applicable
Governmental Entity. The Company shall be responsible for making any required
filing with respect to any Product Registration in connection with such change
in manufacturer or source of manufacturing. BMS shall bear all costs incurred by
either Party with respect to such change in manufacturer or source of
manufacturing including without limitation any Product Registration filings, and
shall compensate the Company for its Fully-Burdened Costs incurred pursuant to
any such change.
(d) At any time and from time to time, BMS in its sole discretion may
change, without the consent of but with sixty (60) days prior written notice to
and consultation with the Company, any manufacturing processes used in
manufacturing the Product, any active pharmaceutical ingredient, intermediates,
excipients, reagents or other compounds used in the manufacture of the Product,
and any
-10-
suppliers of any components used in making the Product; provided that, any such
change requiring approval of an amendment or supplement to any Product
Registration will not be effected or implemented without the prior written
consent of the Company (not to be unreasonably withheld or delayed); and
provided further that except where such change results from a manufacturing
Improvement made in response to a pronouncement of a Governmental Entity (other
than as a result of non-compliance by BMS), a Force Majeure Event, or a change
in applicable Law, no such change shall be effected in a manner that would
result in or cause an interruption of supply of the Product to the Company. Each
Party will fully cooperate with the other in any reasonable manner to effect
such change in a timely manner. The Company shall be responsible for all Product
Registration filings needed to effect such change, and will use its commercially
reasonable efforts to make all such regulatory filings (subject to receipt of
necessary information from BMS) and take such actions as may be required to
implement and seek regulatory approval for such change on a timely basis. BMS
shall be responsible for making any required filing to any Manufacturing
Facility Registration with respect to such change and seeking approval from each
applicable Governmental Entity, BMS shall reimburse the Company for its
Fully-Burdened Costs in seeking and obtaining or assisting BMS in seeking and
obtaining any qualification or regulatory approval of such change. However, if
such change is required by a change in Law or by a Governmental Entity (other
than as a result of non-compliance by BMS), or is requested by the Company, in
which event the Company shall reimburse BMS for its Fully-Burdened Costs plus
15% to seek and obtain any regulatory approval for such change and to implement
such change.
(e) With respect to any regulatory filings and approvals made or
sought by either Party under this Section 2.06, each Party shall provide
reasonable cooperation to the other Party in connection therewith. If a change
proposed to be made under this Section 2.06 requires prior approval by any
applicable Governmental Entity before implementation, such change will not be
implemented until such change has been so approved.
Section 2.07. Material Safety Data Sheets.
BMS shall provide the Company with all information in the applicable
Material Safety Data Sheets as they exist as of the Effective Date for the
Product provided by BMS and thereafter as reasonably requested by the Company.
Section 2.08. BMS Supply Contracts.
BMS shall have the sole right, but not the obligation, at its sole
discretion and expense, to maintain and enforce any contract entered into by BMS
or its Affiliates covering the supply of any active pharmaceutical ingredient,
compounds, intermediates, biomaterials, packaging components, containers and
other materials used in the manufacture of the Product. Upon termination of BMS'
supply obligation under this Agreement, BMS will assign, to the extent
assignable and if requested by the Company, any contracts relating to the supply
of any active pharmaceutical ingredient, compounds, intermediates, biomaterials,
packaging components, containers and other material used exclusively in the
manufacture of the Product, and the Company shall be solely responsible for all
obligations arising under such assigned contracts after the date of assignment.
Except as provided by Section 11, nothing contained in this Section 2.08 shall
excuse BMS from performing its obligations under this Agreement. For the
avoidance of doubt, termination without cause by BMS and/or expiration of a
supply contract by BMS, in itself, does not constitute a Force Majeure event;
provided, however, BMS' inability to obtain bulk supply shall constitute a Force
Majeure event.
Section 2.09. Line Extension Product and New Product.
-11-
BMS shall have no obligation, express or implied, to develop or assist
in the development or manufacture of new formulations, dosages, forms of
administration or preparations for the Product.
Section 2.10. Maintenance of Manufacturing Facility Registrations.
For so long as BMS is manufacturing the Product for the Company:
(a) BMS shall have sole responsibility at its expense for maintaining,
and shall use commercially reasonable efforts to maintain, each Manufacturing
Facility Registration covering the manufacture of the Product.
(b) The Company agrees to provide to BMS all material manufacturing
and supply information (the "Facility Technical Information") necessary to
enable BMS (i) to make any filings required by applicable Law in connection with
any Manufacturing Facility Registration, (ii) to otherwise maintain each such
Manufacturing Facility Registration, and (iii) to include complete and accurate
information in reports required to be made by BMS to any applicable Governmental
Entity with respect to any Product with respect to such Manufacturing Facility
Registration. BMS shall, to the extent it is not required to be reported to BMS
by the Company under applicable Laws, provide written notice to Company setting
forth in reasonable detail the nature of the Facility Technical Information in
respect of the Product and the date by which such Facility Technical Information
shall be provided to BMS in respect of the Product. Any such written notice
shall allow the Company reasonable time to accumulate such Facility Technical
Information requested. The Company shall use its commercially reasonable efforts
to provide such Facility Technical Information to BMS on or before the date set
forth in any such written request. The Company will use its commercially
reasonable efforts to do all such other acts, as promptly as reasonably
possible, which may be necessary or appropriate to make all necessary reports to
BMS to allow appropriate and timely filings required by Law to the Manufacturing
Facility Registration. BMS shall reimburse the Company its Fully-Burdened Costs
to provide such information and reports.
(c) Each Party shall keep the other informed on a timely basis as to
any developments that would have a material adverse effect on a Manufacturing
Facility Registration. BMS shall have the final decision-making authority in
every case on how to maintain each Manufacturing Facility Registration and any
other issues in connection therewith; provided, that, BMS will not, except where
required by, or to fulfill its obligations under, applicable Laws or except
where required by a Governmental Entity acting within the scope of its
authority, supplement, amend or otherwise alter a Manufacturing Facility
Registration so as to breach this Agreement or to materially and adversely alter
the rights granted to, or the obligations imposed upon, the Company hereunder or
under the Asset Purchase Agreement that are derived from such Manufacturing
Facility Registration.
Section 2.11. Maintenance of Product Registrations.
(a) As between the Parties, the Company shall retain all rights, title
and interests in and to, and all obligations under, the Product Registration.
The Company shall have sole responsibility for maintaining, and shall use
commercially reasonable efforts to maintain, the Product Registration, including
filing NDA annual reports.
(b) Without limiting any obligations of BMS under the Asset Purchase
Agreement, BMS agrees to provide all material information (the "Technical
Information") necessary to enable the Company (i) to make any filings required
by applicable Law in connection with any Product Registrations anywhere in the
world, (ii) to otherwise maintain any Product Registrations anywhere in the
world (including any Supplemental Registrations), and (iii) to include complete
and accurate information in the
-12-
annual reports required to be made by the Company to the FDA in relation to the
Product. The Company shall, to the extent it is not required to be reported to
the Company by BMS under applicable Laws and/or as listed on Form FDA 2252,
provide written notice to BMS setting forth in reasonable detail the nature of
the Technical Information in respect of the Product and the date by which such
Technical Information shall be provided to the Company in respect of the
Product. Any such written notice shall allow BMS reasonable time to accumulate
such Technical Information requested. BMS shall use its commercially reasonable
efforts to provide such Technical Information to the Company on or before the
date set forth in any such written request. BMS will use its commercially
reasonable efforts to do all such other acts, as promptly as reasonably
possible, which may be necessary or appropriate to make all necessary reports to
the Company, including reports of Serious and Non-Serious Adverse Events in
accordance with Section 8.03, that are required by Law to allow appropriate and
timely filings to the Product Registration. Except as otherwise provided in the
Asset Purchase Agreement, the Company shall reimburse BMS its Fully-Burdened
Costs plus 15% to provide such information and reports with respect to Product
Registrations outside the U.S.
(c) Each Party shall keep the other informed on a timely basis as to
any developments that would have a material adverse effect on the Product
Registrations. Where the Company may lawfully do so and subject to any
confidentiality obligations it may have to Third Parties with respect to Third
Party information included therein, the Company shall provide BMS, upon request
after reasonable notice from BMS, with access to copies of all filings submitted
by the Company based on any information submitted by BMS or that relate to any
Facility. The Company shall have the final decision-making authority in every
case on how to maintain each Product Registration and any other issues in
connection therewith, provided, however, Company shall consult with BMS, on
whether and how to communicate with applicable Governmental Entity with respect
to decisions on Recall of the Product. The Company will not, except where
required by, or to fulfill its obligations under, applicable Law or except where
required by a Governmental Entity acting within the scope of its authority,
supplement, amend or otherwise alter any Product Registration so as to breach
this Agreement or to materially and adversely alter the rights granted to, or
the obligations imposed upon, BMS hereunder or under the Asset Purchase
Agreement that are derived from such Product Registration.
(d) The Company shall pay all fees arising on or after the Effective
Date with respect to the Product Registrations that the Company initiates,
including NDA user and filing fees.
Section 2.12. Promotional and Advertising Materials.
The Company shall be solely responsible for designing, preparing and
distributing at its sole expense all promotional materials and advertisements
used by or on its behalf of it in the promotion and marketing of the Product.
The Company shall be solely responsible for submitting, without BMS review, all
promotional and advertising materials prepared by or for it to Governmental
Entity for review and approval (as applicable). Notwithstanding any review or
use of any promotional or advertising materials by BMS prior to the Effective
Date, the Company will be solely responsible and liable for any failure arising
after the Effective Date of such materials to comply with the applicable
labeling and Product Registration and with applicable Law (including the
Prescription Drug Marketing Act of 1987 ("PDMA") and any amendments thereto),
unless the failure to so comply is a result of BMS' or its Affiliate's act or
omission with respect to such promotional and advertising materials, including
packaging errors and omissions, in which case BMS shall be solely responsible
and liable.
Section 2.13. Intellectual Property; License Grant.
(a) The Company hereby grants to BMS a non-exclusive, fully paid-up
and royalty-
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free, irrevocable, worldwide and sublicensable right and license under its
rights, title and interests in and to the Partnership Manufacturing Know-How,
the Xxxxxxxx Know-How and the BMS Know-How, in each case solely for purposes of
manufacturing and supplying the Product exclusively to the Company during the
Term and under the provisions of this Agreement.
(b) As between the Parties, the Company shall own all right, title and
interest in and to the Partnership Manufacturing Know-How, including, without
limitation, to any Improvements thereto.
(c) BMS hereby grants to Company a non-exclusive, fully paid-up and
royalty-free, irrevocable, worldwide and sublicensable right and license under
its rights, title and interests in and to the BMS Manufacturing Know-How solely
for the purpose of manufacturing or having manufactured the Product and any
Improvements thereto for the Company's manufacturing, marketing, sale and
distribution.
SECTION 3.
PURCHASE PRICE FOR PRODUCT
Section 3.01. Purchase Price.
(a) The purchase price for commercial and sample supplies of the
Product sold to the Company during the Term pursuant to Firm Orders submitted by
Company shall be equal to the price set forth in Schedule 3.01(a) (as adjusted
from time to time pursuant to Section 3.01(b), the "Purchase Price").
(b) The Purchase Price for the Product shall be fixed at the beginning
of the Term, and thereafter shall be adjusted on January 1, 2003 and on each
January 1 thereafter during the Term (to take effect for orders to be delivered
after January 1) to be equal to [***] for such calendar year as calculated by
BMS in accordance with its standard accounting procedures in or about September
of the preceding calendar year. The Purchase Price may not be increased in any
annual adjustment pursuant to this Section 3.01(b) in excess of five percent
(5.0%) of the Purchase Price in effect for the immediately preceding calendar
year. For the avoidance of doubt, this limitation shall not apply to any
increase to the Purchase Price pursuant to an adjustment under Section 3.01(c).
(c) In addition to any Purchase Price adjustment pursuant to Section
3.01(b), BMS shall be entitled to increase the Purchase Price for the Product at
any time during the Term (to take effect for orders to be delivered after the
date of such event) by giving thirty (30) days prior written notice to the
Company solely to take into account, to the extent not reimbursed by the
Company: (i) any increase in the Fully-Burdened Costs of manufacturing the
Product occasioned by a change in Specifications requested by the Company
pursuant to Section 2.06(b); (ii) changes in its manufacturing processes in
response to a pronouncement of a Governmental Entity (other than as a result of
non-compliance by BMS), (iii) changes resulting from a Force Majeure Event, or a
change in applicable Law pursuant to Sections 2.06(c) and 2.06(d); or (iv) to
reflect unanticipated, significant, additional costs incurred upon renewal or
replacement of any contract with a Third Party for the supply of any materials
or services used in the manufacture or supply of the finished Product, but
excluding for purposes of this clause (iv) any costs incurred in connection with
the change of the manufacturer or source of manufacturing of the Product. In
connection with any increase of the Purchase Price pursuant to the preceding
sentence, BMS shall provide reasonable documentation to the Company supporting
the basis for the increase and shall use its commercially reasonable efforts to
locate an alternative lower cost supplier for materials or provider of
***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-
services utilized to manufacture the Product. Since such increases may not be
immediately known at the effective date of the price increase, the Purchase
Price for any deliveries made after the effective date of such price increase
will be invoiced and initially paid based on the Purchase Price then in effect,
with an adjustment of the Purchase Price and payment of any difference to be
made once the adjustment is finally determined.
(d) Not more frequently than once with respect to any year in
which BMS has elected to adjust the Purchase Price under Section 3.01(b) or
Section 3.01(c), the Company shall have the right within twelve (12) months of
such Purchase Price adjustment, to have an independent accounting firm audit
BMS' books and records relating to such price adjustment, for the sole purpose
of verifying BMS' determination of the adjustment. Such audit shall be at
reasonable times during normal business hours and upon reasonable notice to BMS.
Concurrently with the auditing firm's furnishing of its conclusions to the
Company, a copy of such conclusions shall be furnished to BMS to allow BMS an
opportunity to review the accuracy of the auditing firm's conclusions. The
parties shall cooperate with one another in good faith to resolve any disputes
concerning the auditing firm's conclusions in accordance with Section 14.03. The
Company shall bear the full cost of such audit unless such audit discloses a
variance of more than five percent (5%) from the amount due, in which event, BMS
shall bear the full cost of such audit. Any amounts that are determined to be
due and owing by BMS to the Company following such audit shall be paid within
thirty (30) days thereafter, together with any interest due thereon from the
date of overpayment by the Company at the Prime Rate plus one percent (1%) per
annum; provided that in no event shall such rate exceed the maximum legal annual
interest rate. The payment of such interest shall not limit the Company from
exercising any other rights or remedies it may have. If such audit right is not
exercised by the Company within the twelve (12) month time period, then such
price increase shall be deemed accepted.
SECTION 4.
PAYMENTS AND REPORTS
Section 4.01. Payment; Books and Records.
(a) BMS shall submit invoices to the Company for the Product
promptly after shipment. The invoices shall reflect the Purchase Price. Payments
shall be made by the Company within thirty (30) calendar days of receipt of the
invoice or shipment, whichever occurs later. In addition, BMS, in its sole
discretion, shall determine, and may from time to time change without the
consent of, but with notice to, the Company, the identity of the party that
shall invoice the Company for any Product supplied hereunder which shall be BMS
or an Affiliate of BMS.
(b) BMS shall maintain complete and accurate books, records and
accounts that, in reasonable detail, fairly reflect the calculation of
Fully-Burdened Cost of the Product supplied hereunder, in sufficient detail to
permit (i) BMS to prepare financial statements for the supply of Product to the
Company for each calendar quarter and calendar year in conformity with GAAP and
as required by Section 3.01 and (ii) the Company to confirm the accuracy of the
calculation of any Purchase Price invoiced hereunder. BMS shall retain such
books, records and account for a period of not less than three (3) calendar
years after the calendar year in which they are prepared.
(c) Within sixty (60) days after the end of each calendar
quarter, BMS shall provide the Company with the financial statements prepared by
BMS pursuant to Section 4.01(b).
-15-
Section 4.02. Mode of Payment.
The Company shall make all payments required under this
Agreement by electronic transfer of immediately available United States dollars
to a bank account designated by BMS.
Section 4.03. Taxes.
Any and all transfer, sales, use, and other taxes imposed upon
or with respect to or measured by the sale or delivery by BMS to the Company of
any Product hereunder shall be the responsibility of and for the account of the
Company. Such amounts shall be included on BMS' invoices to the Company for the
Product. If BMS obtains any credit for the amounts of the tax, such amount shall
be repaid by BMS to the Company when it is received by BMS. Anything to the
contrary notwithstanding, the Company shall have no obligation to pay any income
tax imposed on BMS or any of its Affiliates which may arise from the
transactions contemplated by this Agreement.
Section 4.04. Late Payments.
In the event that any payment due hereunder is not made when
due, the payment shall accrue interest from the date due at Prime Rate plus one
percent (1%) per annum, provided, that, in no event shall such rate exceed the
maximum legal annual interest rate. The payment of such interest shall not limit
BMS from exercising any other rights it may have as a consequence of the
lateness of any payment.
SECTION 5.
COMPLIANCE WITH LAWS; REPRESENTATIONS AND WARRANTIES
Section 5.01. Compliance with Law; Cooperation.
(a) Compliance with Law. Each Party shall maintain in full
force and effect all necessary licenses, permits and other authorizations
required by applicable Law to carry out its duties and obligations under this
Agreement. Each Party shall comply with all Laws applicable to its activities
under this Agreement, including, without limitation, any requirements of any
product license applicable to the Product and all applicable U.S. federal, state
and local environmental health and safety laws then in effect. The Company shall
store, market, promote, advertise and sell the Product sold to it by BMS in
compliance with all applicable Laws, including the PDMA. BMS and the Company
each shall keep all records and reports required to be kept by applicable Laws.
The Parties will reasonably cooperate with one another with the goal of ensuring
full compliance with Laws. Each Party will cooperate with the other to provide
such letters, documentation and other information on a timely basis as the other
Party may reasonably require to fulfill its reporting and other obligations
under applicable Laws to applicable Governmental Entity.
(b) Reasonable Cooperation. Without limiting any obligation
expressly imposed on either Party pursuant to the other provisions of this
Agreement, BMS and the Company each hereby agrees to co-operate in good faith
with one another, particularly with respect to unanticipated problems or
contingencies, and shall perform its respective obligations in good faith and in
a commercially reasonable, diligent and workmanlike manner, and use its
commercially reasonable efforts to take, or cause to be taken, all actions and
to do, or cause to be done, all things necessary or proper to make effective the
transactions contemplated by this Agreement, including such actions as may be
reasonably necessary to
-16-
obtain approvals and consents of Governmental Entities and other Persons,
provided, that, no Party shall be required to (i) pay money (other than as
expressly required pursuant to the terms and conditions of this Agreement or
Related Instruments), or (ii) assume any other material obligation not otherwise
required to be assumed by this Agreement or any Related Instruments.
(c) Right to Audit. Not more frequently than once in any
calendar year, the Company shall afford BMS or BMS' representatives, upon not
less than ten (10) calendar days' prior written notice and during normal
business hours of Company, reasonable access to (i) the premises where the
Product is being handled and stored, and (ii) the personnel dedicated to the
handling and storing of such Product, to the extent necessary to inspect and
conduct a reasonable audit thereof (the "Facility Audit") with respect to the
performance of Company's obligations under all applicable Laws and compliance
with the handling and storing requirements of the Specifications; provided,
that, such access does not unreasonably disrupt the normal operations of
Company. BMS, in its sole discretion, may make recommendations regarding the
handling or storage of the Product which may be implemented by the Company in
its sole discretion. Notwithstanding this provision, all responsibility
regarding the handling and storage of the Product is with the Company once the
Product is shipped from BMS' Facility in accordance with the terms set forth in
Section 2.04.
Section 5.02. BMS Representations, Warranties and Covenants.
(a) BMS represents, warrants and covenants to the Company that
the Product manufactured by or for BMS and sold to the Company under this
Agreement will, at the time it is tendered to the common carrier for delivery to
the Company, except to the extent such non-compliance is attributable to
specific instructions received from the Company:
(i) not be adulterated or misbranded under applicable
Law;
(ii) meet the Specifications therefor;
(iii) be manufactured, tested, labeled, packaged, stored,
handled, and shipped, in compliance in all material respects
with cGMP and with any other applicable Laws, including all
applicable U.S. federal, state and local environmental health
and safety laws in effect at the time and place of manufacture
of the Product;
(iv) will be free from defects in material, manufacturing
and workmanship when delivered to the common carrier, provided
that BMS makes no representation or warranty in this clause (iv)
with respect to any defects or non-conformity that can not be
readily tested or seen;
(v) have a shelf life of not less than eighty-two
percent (82%) of the shelf life set forth in Schedule 1.01. In
the event that the shelf life of any Product is approved to be
extended, then the Parties will discuss in good faith an
adjustment to this representation to fairly reflect such
extension.
-17-
(b) BMS represents and warrants to the Company that, as of the
Effective Date, there is no claim, suit or proceeding, or other investigation
pending, or to the actual knowledge of BMS, threatened in writing against BMS
which is likely to prevent or materially interfere with BMS' performance under
this Agreement or materially adversely affect the rights and interests of the
Company hereunder.
(c) BMS represents, warrants and covenants to the Company that
BMS, its Affiliates, licensees and contractors shall adhere in all material
respects to all applicable Laws relating to the manufacture, handling, storage,
and disposal by any of them of the Product.
(d) BMS represents and warrants to the Company that the prices
set forth on Schedule 3.01(a) do not exceed [***] for calendar year 2002 as
calculated by BMS in accordance with its standard accounting procedures in or
about September of 2001.
Section 5.03. The Company Representations, Warranties and Covenants.
The Company represents, warrants and covenants to BMS that the
Company, its Affiliates, licensees and contractors shall adhere in all material
respects to all applicable Laws relating to the handling, storage, sale,
distribution and disposal by any of them of the Product except to the extent
such non-compliance is attributable to specific instruction received from BMS.
Section 5.04. Representations and Warranties of Each Party.
(a) Each Party hereby represents and warrants to the other
Party as of the Effective Date as follows:
(i) such Party (A) has the power and authority and the
legal right to enter into this Agreement and perform its
obligations hereunder, and (B) has taken all necessary action on
its part required to authorize the execution and delivery of
this Agreement and the performance of its obligations hereunder.
This Agreement has been duly executed and delivered on behalf of
such Party and constitutes a legal, valid, binding obligation of
such Party and is enforceable against it in accordance with its
terms subject to the effects of bankruptcy, insolvency, or other
laws of general application affecting the enforcement of
creditor rights and judicial principles affecting the
availability of specific performance and general principles of
equity, whether enforceability is considered a proceeding at law
or equity.
(ii) such Party is not aware of any pending or threatened
litigation (and has not received any communication) that alleges
that such Party's activities related to this Agreement have
violated, or that by conducting the activities as contemplated
herein such Party would violate, any of the intellectual
property rights of any other Person.
(iii) all necessary consents, approvals and authorizations
of all governmental authorities and other Persons required to be
obtained by such Party in connection with this Agreement have
been obtained.
(iv) the execution and delivery of this Agreement and the
performance of such Party's obligations hereunder (A) do not
conflict with or violate any requirement of applicable law or
regulation or any provision of articles of incorporation, bylaws
or
***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.
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limited partnership agreement of such Party, as applicable, in
any material way, and (B) do not conflict with, violate, or
breach or constitute a default or require any consent under, any
contractual obligation or court or administrative order by which
such Party is bound.
Section 5.05. Disclaimer of Warranties.
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE ASSET
PURCHASE AGREEMENT OR ANY RELATED AGREEMENT, THERE ARE NO OTHER REPRESENTATIONS
OR WARRANTIES, EXPRESS OR IMPLIED, MADE OR GIVEN BY EITHER PARTY HEREUNDER,
INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF QUALITY, PERFORMANCE,
MERCHANTABILITY AND FITNESS FOR A PARTICULAR USE OR PURPOSE OF A PRODUCT OR
ABSENCE OF INFRINGEMENT OF THIRD PARTY RIGHTS WITH RESPECT TO THE MANUFACTURE,
USE OR SALE OF A PRODUCT.
Section 5.06. No Reliance by Third Parties.
The representations and warranties of a Party set forth in this
Agreement are intended for the sole and exclusive benefit of the other Party
hereto, and may not be relied upon by any Third Party.
SECTION 6.
INDEMNIFICATION; REMEDIES FOR BREACH
Section 6.01. BMS Indemnity.
Subject to the Company's indemnity obligations under Section
6.02, BMS shall defend, indemnify and hold harmless the Company, its Affiliates,
and its and their employees, agents, officers, and directors (a "Company Party")
from and against any and all Losses that result from or arise in connection with
any claim (including, product liability claims, strict liability or tort
claims), action, suit or other proceeding made or brought by or on behalf of a
Third Party against a Company Party (including claims, actions, suits or
proceedings for bodily injury, death or property damage), in any such case,
based on the breach of any representation or warranty of BMS contained in
Section 5.02 or breach of any material obligation of BMS of this Agreement;
provided, however, that BMS shall not be obligated to indemnify a Company Party
for any Losses incurred by such Company Party to the extent attributable to any
breach of this Agreement by the Company, a Company Party or the Company's
contractors/licensees, or to any act or omission constituting gross negligence
or willful misconduct on the part of the Company, a Company Party or the
Company's contractors/licensees, or any action taken by BMS or its Affiliate
upon the direction of the Company (including pursuant to amendments or
modifications made to the Specifications by the Company) or to any failure of a
Company Party to identify or bring to BMS' attention a Product defect or
non-conformity actually known by such Company Party prior to the use of such
Product by a Third Party.
Section 6.02. The Company Indemnity.
Subject to BMS' indemnity obligations under Section 6.01, the
Company shall defend, indemnify and hold harmless BMS, its Affiliates, and its
and their employees, agents, officers, and directors (a "BMS Party") from and
against any and all Losses that result from or arise in connection with (a) any
claim (including product liability claims, strict liability or tort claims),
action or proceeding made or brought against such BMS Party by or on behalf of a
Third Party for bodily injury, death or property
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damage to the extent such injury, death or damage is based on (i) the Company's
use, promotion, advertising, handling, disposal or supply of the Product after
the Effective Date (regardless of which Party manufactured it) or (ii) the
Company's breach of this Agreement; or (b) any claim, action, suit or other
proceeding made or brought by a Third Party based on (i) the breach by the
Company of any of its representations or warranties contained in Section 5.03 or
breach of any material obligation of Company under this Agreement, including
breach of applicable Law; or (ii) infringement of a Third Party's trademarks or
copyrights by reason of Company's specified labeling of the Products or any
materials used in promoting or advertising the Product, or (iii) in the event
that any changes are made to the Product (including, without limitation, changes
to the Specifications, formulation or manufacturing process used to manufacture
the Product) after the Effective Date, infringement of a Third Party's patent
rights by reason of the manufacture, use, import, export, or sale of the Product
after the effective date of such change; provided, however, that the Company
shall not be obligated to indemnify a BMS Party for any Losses incurred by such
BMS Party to the extent attributable to a breach by BMS of this Agreement, or to
any act or omission constituting gross negligence or willful misconduct on the
part of BMS or a BMS Party.
Section 6.03. Limitations on Liability and Remedies.
Notwithstanding any other provision in this Agreement, no Party
shall in any event be liable to the other Party or its Affiliates, officers,
directors, employees, stockholders, agents or representatives on account of any
breach hereof or any indemnity obligation set forth herein for any indirect,
special, consequential or punitive damages (including, but not limited to, lost
profits, loss of use, damage to goodwill or loss of business that maybe incurred
or claimed by such other Party or its Affiliates, officers, directors,
employees, stockholders, agents or representatives or by a Third Party for which
indemnification is sought hereunder.
Section 6.04. Control of Proceedings.
(a) To receive the benefits of the indemnity under Sections
6.01 or 6.02, as applicable, an indemnified Party must (i) give the indemnifying
Party written notice of any claim or potential claim promptly after the
indemnified Party receives written notice of any such claim and (ii) allow the
indemnifying Party to assume exclusive control of the defense and settlement
(including all decisions relating to litigation, defense and appeal) of any such
claim, provided, that, (i) the controlling Party has confirmed its
indemnification obligation to such indemnified Party under this Section 6.04
with respect to a given claim), and (ii) such controlling Party may not settle
such claim or enter into any voluntary consent judgment in any manner that would
(w) require payment by the other Party, (x) materially adversely affect the
rights granted to the other Party hereunder, (y) make any admission of
wrongdoing or fault of any Party without such Party's prior written consent, or
(z) materially conflict with the terms of this Agreement, without first
obtaining the other Party's prior written consent.
(b) The indemnified Party shall (so long as such cooperation
does not vitiate any legal privilege to which it is entitled) reasonably
cooperate with the indemnifying Party in its defense of the claim (including
making documents and records available for review and copying and making persons
within its/his/her control available for pertinent testimony). If the
indemnifying Party defends the claim, an indemnified Party may participate in,
but not control, the defense of such claim using attorneys of its/his/her choice
and at its/his/her sole cost and expense. An indemnifying Party shall have no
obligation or liability under this Section 6 as to any claim for which
settlement or compromise of such claim is made by an indemnified Party without
the prior written consent of the indemnifying Party.
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(c) If the indemnifying Party notifies the other in writing
that it will not defend the other Party against such claim asserted against the
other Party, or if the indemnifying Party fails to defend or take other
reasonable, timely action, in response to such claim asserted against the other
Party, the indemnified Party shall have the right, but not the obligation, to
defend or take other reasonable action to defend its interests in such
proceedings, and shall have the right to litigate, settle or otherwise dispose
of any such claim without limiting its rights to indemnification under this
Section 6; provided, however, that the Party shall not have the right to settle
such claim or enter into a consent judgment in a manner that adversely affects
the rights granted to the indemnifying Party hereunder, or would materially
conflict with this Agreement, or would require a payment by the indemnifying
Party without the prior written consent of the Party entitled to control the
defense.
Section 6.05. Insurance.
(a) The Company will maintain comprehensive general liability
insurance on a claims-made basis, with endorsements for contractual liability
and product liability with coverage limits of not less than (i) Fifteen Million
Dollars ($15,000,000) per occurrence or in the aggregate, at all times
commencing on the Effective Date and continuing through the date that is sixty
(60) days following the Effective Date, and (ii) Twenty Million Dollars
($20,000,000) per occurrence or in the aggregate, at all times from and after
the date that is sixty (60) days following the Effective Date and continuing
during the period that any Product is being distributed or sold by or through
the Company hereunder, and for fifteen (15) years thereafter. The minimum level
of insurance set forth herein shall not be construed to create a limit on the
Company's liability hereunder. On each of the Effective Date and the date that
is sixty (60) days following the Effective Date, the Company shall furnish to
BMS a certificate of insurance evidencing such coverage as of such date. Each
such certificate of insurance, as well as any certificates evidencing new or
modified coverages of the Company, shall include a provision whereby sixty (60)
days written notice must be received by BMS prior to coverage modification or
cancellation by either the Company or the insurer. In addition, the Company
shall promptly notify BMS of any cancellation or modification of such insurance
coverage and of any new or modified coverage. In the case of a modification or
cancellation of such coverage, the Company shall promptly provide BMS with a new
certificate of insurance evidencing that the Company's coverage meets the
requirements in the first sentence of this Section.
(b) BMS will maintain at all times during the period that any
Product is being supplied to the Company by BMS, and is being manufactured by or
for BMS, and for fifteen (15) years thereafter, a commercially reasonable
program of self-insurance and insurance consistent with, or more comprehensive
than, industry standards on a claims-made basis with respect to its obligations
under this Agreement. BMS further agrees that the Company shall have the benefit
of an additional insured party of not less than the first Twenty Million Dollars
($20,000,000) per occurrence or in the aggregate in any policies of insurance
maintained by BMS with respect to product liability relating to the Product,
including the equivalent of such status as an additional named insured party for
purposes of BMS' self-insurance.
Section 6.06. Other Limitations on Liability.
(a) Any action for breach of this Agreement by a Party arising
during the Term must be commenced within twelve (12) months after the end of the
Term, provided nothing in this Section 6.06(a) shall apply to any claim by
either Party for indemnification under Section 6.01 or 6.02, or to any claim by
either Party for breach of the other Party's indemnity obligation.
(b) BMS and the Company shall cooperate with each other in
resolving any claim or
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liability with respect to which a Party is obligated to indemnify the other
under this Agreement, including without limitation, by making commercially
reasonable efforts to mitigate or resolve any such claim or liability.
Section 6.07. Calculation of Losses.
The amount of any Loss for which indemnification is provided
under Section 6.01 or Section 6.02 shall be net of any amounts actually
recovered by the indemnified party under insurance policies (after reduction for
any costs or expenses incurred in connection therewith, including, retrospective
and prospective premium adjustments, experience-based premium adjustments) with
respect to such Loss, and shall be reduced to take account of any net tax
benefit of the indemnified party arising from the occurrence or payment of any
such Loss which is actually recognized via a reduction of income tax liability
that would have otherwise been due in the tax year such Loss is claimed (or, if
applicable, in a prior year as a result of a carryback) on the indemnified
party's federal and state income tax returns or within the four (4) succeeding
tax years of the indemnified party. In computing the amount of such net tax
benefit, the indemnified party shall be deemed to recognize all other items of
income, gain, loss, deduction or credit before recognizing any item arising from
the receipt or accrual of the right to receive any indemnity payment under
Section 6.01 or Section 6.02 or the incurrence or payment of any indemnified
Loss. Further, if a net tax benefit results in a tax year after the tax year the
loss was originally claimed by the indemnified party, the net tax benefit shall
be computed by computing the present value thereof using a discount rate of ten
percent (10%). Any indemnity payment under Section 6.01 or Section 6.02 shall be
treated as an adjustment to the Purchase Price for tax purposes, unless a final
determination with respect to the indemnified party or any of its Affiliates
causes any such payment not to be treated as an adjustment to such price for
federal income tax purposes.
SECTION 7.
COMPLIANCE WITH GOVERNMENT REGULATIONS
Section 7.01. Government Communications.
BMS shall be responsible for all communications with any
Governmental Entity relating to BMS' manufacturing activities, including
Facility inspections by Governmental Entities, under this Agreement and the
Company shall be responsible for all communication with any Governmental Entity
concerning the marketing, distribution, or sale of the Product; provided that
the parties agree that the Company and not BMS shall be responsible for and
shall engage in all communications with Governmental Entities with respect to
the Product Registrations, unless BMS is required to participate in any
communications by any Governmental Entity.
Section 7.02. Access to Records.
The Company shall have, in connection with any Audit under
Section 7.04, reasonable access to BMS' files, during normal business hours,
from time to time upon reasonable prior notice, to review all such records,
correspondence, notices, documents, and other materials (including warning
letters and letters of adverse findings) relating to the manufacture of the
Product; provided, however, that such access does not unreasonably disrupt the
normal operation of BMS.
Section 7.03. Governmental and Regulatory Inspections.
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BMS shall notify the Company immediately by telephone and in
writing of any inspections conducted by any Governmental Entity of the premises
where the Product is being manufactured, to the extent such inspection relates
to the manufacture of the Product, and shall provide to the Company copies of
all correspondence, reports, notices, findings and other material pertinent to
such inspections and that specifically relate to the Product. BMS may redact
portions that do not specifically relate to the Product.
Section 7.04. The Company Inspections.
BMS shall, or if BMS is not manufacturing the Product, BMS shall
use its commercially reasonable efforts to cause the Person manufacturing such
Product to afford the Company or the Company's representatives, upon not less
than thirty (30) calendar days prior written notice and during normal business
hours for BMS or such Person, and not more than once per calendar year (such
Audit to cover all Products and all Facilities), reasonable access to (i) the
premises where the Products are being tested and/or manufactured, and (ii) the
personnel dedicated to the manufacturing, processing, analytical testing,
packaging, labeling and storing of such Product, to the extent necessary to
inspect and conduct a reasonable audit ("Audit") thereof with respect to the
performance of BMS' obligations hereunder; provided, that, such access does not
unreasonably disrupt the normal operations of BMS or such other manufacturer.
Such Audit shall be carried out in a manner that ensures the continued
confidentiality of BMS' business and technical information, including the
execution of such appropriate confidentiality agreements as BMS may reasonably
request in advance of any such Audit. Within thirty (30) calendar days of
completing any such Audit hereunder, the Company shall submit to BMS a written
report outlining its findings and/or observations from any such Audit. If
deficiencies are discovered during an Audit that could, in the Company's
opinion, prevent BMS from satisfying its supply obligations hereunder, and BMS
in good faith disputes the observations or conclusions of the Company, then the
Parties shall promptly enter into good faith discussions to resolve their
differences.
Section 7.05. Regulatory Matters.
(a) General Compliance. BMS will, at its sole expense, comply
with all Laws applicable to production, testing, storage, shipment, and record
keeping by BMS of the Product and its performance of its obligations hereunder,
including all applicable Laws or requirements under any applicable Product
Registrations or Manufacturing Facility Registrations. During any period that
BMS manufactures the Product for the Company, except as otherwise expressly set
forth in this Agreement, (i) BMS will pay any fees necessary to obtain and
maintain Manufacturing Facility Registrations and any other licenses,
registrations, permits, exemptions, allowances, authorizations, or approvals
from a Governmental Entity which are applicable to a Facility used by BMS to
manufacture the Product, and (ii) the Company shall pay all other fees, costs or
expenses necessary to maintain or obtain licenses, registrations, permits,
exemptions, allowances, authorizations, or approvals from a Governmental Entity
which are applicable to the use, promotion, advertising or sale of such Product,
including all NDA user fees (or similar or substitute fees) applicable to the
Product, other than facilities or establishment fees not specific to the
Product. During any period that the Company maintains the Product Registration
and manufactures the Product, the Company will, at its sole expense, comply with
all Laws applicable to it with respect to the production, testing, storage,
shipment, and recordkeeping of the Product, including all applicable Laws or
requirements under any applicable Product Registrations or Manufacturing
Facility Registrations and will, except as otherwise expressly set forth in this
Agreement, pay all filing, user and similar (or substitute) fees required in
connection with obtaining, maintaining, changing or supplementing any applicable
Product Registration or Manufacturing Facility Registration. At the Company's
request, BMS shall cooperate with the Company in (i) maintaining any applicable
Product Registration, including cooperation in the preparation of NDA annual
reports with respect to the Product, and (ii) responding to
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any Governmental Entity inquiry or request for inspection.
(b) Validations and Qualifications. BMS will perform, at its
own costs, process and cleaning validation, analytical methods validation,
installation/operating qualification, and calibration of all equipment and
Facilities utilized in the manufacture, packaging, labeling, testing, storing,
and release of finished Product in accordance with all Laws. The Parties
acknowledge and agree that BMS will include its costs for performing the
foregoing into its calculation of Fully-Burdened Cost of the Product. The
Company will have the right to review the results thereof during an Audit or in
conjunction with a new process or equipment. In general, BMS will, at all times
in the performance of its obligations hereunder, comply with its standard
operating procedures for the Product and will make copies of such standard
operating procedures available to the Company for review during Company Audits
permitted hereunder.
(c) Batch Records. Batch records, including information
relating to the manufacturing, packaging, labeling, and quality control testing
and analysis for each lot of finished Product produced hereunder, will be
prepared as and when BMS performs any such tasks, in accordance with applicable
Laws and BMS' then current standard operating procedures. Batch records and all
other records relating to production hereunder shall be retained by BMS for the
period required by applicable Laws. Batch records for any SKU of the Product, as
well as updates to the validation package for the Product, will be made
available during an Audit. Upon request of the Company not more than once every
calendar quarter, BMS will copy and provide to the Company batch records for
each SKU of the Product.
SECTION 8.
STABILITY; PRODUCT RECALLS; ADVERSE EXPERIENCES;
PRODUCT QUALITY COMPLAINTS; AND MEDICAL INQUIRIES
Section 8.01. Stability and Quality Control.
(a) Except as otherwise provided in Section 8.01(b), BMS will
be responsible, at its own costs, for taking and maintaining quality control and
stability samples in support of the Product Registrations for the Product, and
for testing stability samples on a timely basis in accordance with applicable
Law, the Product Registrations and BMS' then current standard operating
procedures. The Parties acknowledge and agree that BMS will include its costs
for performing the foregoing into its calculation of Fully-Burdened Cost of the
Product. BMS will make available the stability data (i) for the Product for
review by the Company during any Audit (if the Company gives BMS reasonable
notice to collect and organize same), (ii) in a form suitable for inclusion in
the Company's NDA annual reports with respect to the Product, and as otherwise
reasonably requested by the Company upon the occurrence of an event that may
reasonably be expected to materially and adversely affect the quality or
validity of the stability data. BMS further agrees to maintain all stability
data with respect to the Product in accordance with applicable Laws. BMS will
notify the Company promptly (but at least within at least three (3) business
days of BMS' initiation of an internal investigation of a stability failure with
regard to the Product.
(b) The Parties acknowledge that, pursuant to a requirement
made by the FDA, BMS is currently conducting a post-marketing stability study
with respect to the Product referred to in Paragraph 5 of Schedule 3.09(d) of
the Asset Purchase Agreement (the "Stability Study"). Notwithstanding any other
provision in the Agreement, BMS will be responsible, at its own costs, to
complete the Stability Study, to prepare all reports required to be submitted to
the FDA with respect to the Stability Study, and to handle all communications
with the FDA relating to the Stability Study and any
-24-
changes to the Specifications resulting therefrom (which costs shall not be
included in its Fully-Burdened Cost for the Product); provided that BMS shall
consult with the Company with respect thereto and shall not agree to any changes
to the Specifications without the Company's consent, which shall not be
unreasonably withheld or delayed. In the event that any changes to the
Specifications are required by the FDA, the Company shall reimburse BMS for its
Fully-Burdened Cost plus 15% to implement such change.
Section 8.02. Product Recalls.
In the event that the Company obtains information that a Product
or any portion thereof should be alleged or proven not to meet the
Specifications, labeling or Product Registration for such Product, Company shall
notify BMS immediately after the Company obtains such information and both
Parties shall cooperate fully regarding the investigation and disposition of any
such matter. BMS and the Company shall each maintain such traceability records
as are sufficient and as may be necessary to permit a recall, product withdrawal
or field correction of any Product. In the event (a) any applicable regulatory
authority should issue a request, directive or order that a Product be recalled
or withdrawn, (b) a court of competent jurisdiction orders such a recall or
withdrawal or (c) (i) the Company determines that any Product already in
interstate or international commerce presents a risk of injury or deception or
is otherwise defective and that recall or withdrawal of such Product is
appropriate or (ii) BMS determines that any Product already in interstate or
international commerce presents a risk of injury or deception or is otherwise
defective and that recall or withdrawal of such Product is appropriate and such
determination is consented to in writing by the Company (each of the events in
(a), (b) and (c), a "Recall"), each Party shall give telephonic notice (to be
confirmed in writing) to the other within twenty-four (24) hours of the receipt
of notice of any such event. The Company shall have sole responsibility for
carrying out the Recall, and shall consult with BMS in determining, and
thereafter use commercially reasonable efforts in taking, all corrective action
in connection with a Recall. Each Party will provide full cooperation and
assistance to the other Party in connection therewith as may be requested by the
other Party, including, in the case of the Company, providing BMS within two (2)
business days of receipt by the Company of notice of the Recall a list of
customers who received any recalled or withdrawn Product. The Company shall be
responsible for all expenses of effecting any such Recall (including any
out-of-pocket expenses incurred by the Company and BMS in connection with such
cooperation), except to the extent such Recall is attributable to BMS' failure
to manufacture the Product in accordance with Section 5.02(a) in which event BMS
shall reimburse the Company for its reasonable costs and expenses incurred
(including credits to customers for such Recalls or withdrawal) that are so
attributable to such actions by BMS. Otherwise, all Recalls or withdrawals shall
be solely the responsibility of the Company.
Section 8.03. Adverse Experience.
During the Term, each Party shall promptly notify the other
Party of any significant adverse events that relate to the Product or are
required in accordance with the regulations of relevant Governmental Entities,
including adverse drug experiences and governmental inquiries, and each Party
shall cooperate with the other Party in connection therewith as reasonably
requested by the other Party and as follows:
(a) Serious Adverse Events for the Product of which one (1)
Party becomes aware shall be submitted to the other Party within three (3)
business days but no more than four (4) calendar days from the date the
first-mentioned Party first became aware of such Serious Adverse Event.
Non-Serious Adverse Events for the Product that are reported to one (1) Party
shall be submitted to the other Party no more than one (1) month from the date
received by the first-mentioned Party; provided, however,
-25-
that medical and scientific judgment should be exercised in deciding whether
expedited reporting is appropriate in other situations, such as important
medical events that may not be immediately life-threatening or result in death
or hospitalization but may jeopardize the patient or may require intervention to
prevent a Serious Adverse Event outcome. BMS shall timely provide to the Company
any and all data in BMS' possession relating to the Product manufactured for the
Company by BMS or its Affiliate which is necessary for the Company to timely
complete and submit any adverse event report.
(b) Until the reporting procedures referenced in
Section 8.03(d) herein have been instituted by the Parties, a "Serious Adverse
Event" for the Product shall have the meaning set forth in 21 C.F.R. ss.
314.80(a), as amended from time to time, and a "Non-Serious Adverse Event" for
the Product is defined as an untoward medical occurrence at any dose of the
Product that is not a Serious Adverse Event.
(c) The Company shall have the reporting responsibility for
such events as provided under applicable Laws to applicable regulatory health
authorities. The Company shall report all Serious Adverse Events and all
Non-Serious Adverse Event involving the Product learned by it to:
Director of Quality and Compliance Consolidated Services
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Mail Stop HW19-1.01
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
X.X.X.
Email address: xxxxxxxxx.xxxxxx@xxx.xxx
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
BMS shall report all Serious Adverse Events and all Non-Serious
Adverse Events involving the Product learned by it to:
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Facsimile: (000) 000-00000
Telephone: (000) 000-0000
Attention: Xxxxxxx Xxxxx
A CIOMS-I form or a form that contains the data elements of a
CIOMS-I form is recommended.
(d) As soon as reasonably practicable after the Effective Date,
the Parties shall discuss and develop mutually acceptable guidelines and
procedures for the receipt, recordation, reporting, communication (as between
the parties) and exchange of Serious Adverse Event and Non-Serious Adverse Event
information, as applicable, to the other Party; provided that the Company shall
have exclusive responsibility for communications with Governmental Entities
concerning Serious Adverse Event and Non-Serious Adverse Event information
related to the Product. The Parties shall bear their
-26-
respective costs incurred in connection with receiving, recording, reviewing,
reporting, communicating and exchanging with each other regarding and, as
applicable, reporting and responding to Adverse Events.
(e) At the request of BMS, the Company shall cease reporting
all Serious Adverse Events and all Non-Serious Adverse Events involving the
Product to BMS. BMS shall continue to make such reports to the Company in
accordance with Section 8.03.
Section 8.04. Product Quality Complaints.
(a) The Company shall have sole responsibility, at its expense,
for responding to all Product Quality Complaints received from Third Parties.
BMS shall reimburse the Company for the Fully-Burdened Costs incurred by the
Company for any Product Quality Complaint solely due to a breach of BMS'
representations and warranties set forth in Section 5.02; otherwise the Company
shall bear its own expense of responding to Product Quality Complaints. BMS
shall cooperate to effect any resolutions with respect to the Product Quality
Complaint. "Product Quality Complaint" is defined as any complaint that
questions the purity, identity, potency or quality of the Product, its
packaging, or labeling, or any complaint that concerns any incident that causes
the drug product or its labeling to be mistaken for, or applied to, another
article or any bacteriological contamination, or any significant chemical,
physical, or other change or deterioration in the distributed drug product, or
any failure of one or more distributed batches of the drug product to meet the
specifications therefor in the Product Registration.
(b) Where the subject matter of the Product Quality Complaint
relates in any way to the responsibilities of a Party under this Agreement or
the duties performed by a Party hereunder, such Party will, within three (3)
business days from receipt of written notice from the other Party or receipt by
such Party of any other information from a Third Party constituting the Product
Quality Complaint, initiate a complaint investigation at such Party's expense.
Such Party will conduct such investigation expeditiously. The investigating
Party will report its findings to the other Party's contact listed in Section
8.04(c) or (d) below, as the case may be, within thirty (30) calendar days.
(c) The Company shall inform BMS' contact of any Product
Quality Complaint received by it within three (3) business days from the receipt
date by the Company. Such information shall be sent to BMS as set forth below:
Director of Quality and Compliance Consolidated Services
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Mail Stop HW19-1.01
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
X.X.X.
Email address: xxxxxxxxx.xxxxxx@xxx.xxx
Facsimile No.: (000) 000-0000
Telephone No.: (000) 000-0000
(d) BMS shall inform the Company's contact of any Product
Quality Complaint received by it within three (3) business days from the receipt
date by BMS. Such information shall be sent to the Company as set forth in
Section 8.03(c) below:
Women First HealthCare, Inc.
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00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
Attention: Xxxxx Xxxxxxxxx
(e) Nothing in this Section 8.04 is intended to limit, alter or
restrict a Party's reporting obligations under applicable Law.
Section 8.05. Medical Inquiries.
The Company shall have sole responsibility, at its expense, for
handling all medical inquiries concerning the Product. BMS shall provide to the
Company all medical inquiry files and shall refer all routine medical
information requests in writing to the Company and all urgent medical
information requests to the Company by telephone within three (3) business days
of receipt by BMS. Such information shall be sent to the Company as set forth
below:
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx
Xxx Xxxxx, XX 00000, Suite 400
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
Attention: Xxxxx Xxxxxxxxx
Section 8.06. Disclosure Information.
Both Parties shall be entitled to share information reported to
one another under Sections 8.03, 8.04 and 8.05 with their Affiliates and
licensees to the extent required to meet reporting requirements under applicable
Laws with respect to the marketing, use and sale of any Product. In addition,
such information may be disclosed by one Party upon the prior written consent of
the other Party to any Third Party who manufactured a pertinent component of the
applicable Product for BMS in connection with an investigation of an adverse
event or Product Quality Complaint.
SECTION 9.
CONFIDENTIALITY
Section 9.01. Confidentiality Requirement.
(a) Each Party acknowledges that it may receive confidential or
proprietary information of the other Party in the performance of this Agreement.
Each Party shall use commercially reasonable efforts to safeguard and to hold
such information received by it from the other Party in
-28-
confidence, and shall limit disclosure of the furnishing Party's information to
those employees and consultants of the receiving Party and its Affiliates who
are bound by a written obligation of confidentiality to the receiving Party that
is consistent with the terms of this Section 9. Each Party shall not, directly
or indirectly, disclose, publish or use for the benefit of any Third Party or
itself, except in carrying out its duties hereunder or as otherwise provided in
Section 9.02, any confidential or proprietary information of the other Party,
without first having obtained the furnishing Party's written consent to such
disclosure or use. "Confidential Information" shall include know-how, scientific
information, clinical data, efficacy and safety data, adverse event information,
formulas, methods and processes, specifications, pricing information (including
discounts, rebates and other price adjustments) and other terms and conditions
of sales, customer information, business plans, and all other intellectual
property. This restriction shall not apply to any information within the
following categories:
(i) subject to Section 9.03, information that is known
to the receiving Party or its Affiliates prior to the time of
disclosure to it, to the extent evidenced by written records or
other competent proof;
(ii) information that is independently developed by
employees, agents, or independent contractors of the receiving
Party or its Affiliates without reference to or reliance upon
the information furnished by the disclosing Party, as evidenced
by written records or other competent proof;
(iii) information disclosed to the receiving Party or its
Affiliates by a Third Party that has a right to make such
disclosure; or
(iv) any other information that becomes part of the
public domain through no fault or negligence of the receiving
Party.
The receiving Party shall also be entitled to disclose the other
Party's Confidential Information (1) that is required to be disclosed in
compliance with applicable Laws (including to comply with SEC, NYSE or stock
exchange disclosure requirements) or by order of any Governmental Entity, (2) as
may be necessary or appropriate in connection with the enforcement of this
Agreement or (3) as may be necessary for the conduct of clinical studies,
provided that the Party disclosing such information shall promptly notify the
other Party and shall use commercially reasonable efforts to obtain confidential
treatment of such information by the agency or court or other disclosee, and
that, in the case of disclosures under (1), shall (i) provide the other Party
with prompt prior notice of the proposed disclosure such that the other Party
may seek a protective order or other appropriate remedy and (ii) provide the
other Party with a copy of the proposed disclosure in sufficient time to allow
reasonable opportunity to comment thereon.
(b) The obligations set forth in this Section 9.01 shall
survive the termination or expiration of this Agreement. Nothing in this Section
9 shall be construed to create or imply any right or license under any patent
rights, trademarks, copyrights or other intellectual property rights owned or
controlled by a Party or its Affiliates except as may be expressly set forth in
the other Sections of this Agreement.
(c) The confidentiality obligations set forth in this Section 9
shall supercede the confidentiality obligations set forth in the confidentiality
agreement dated as of February 18, 2002 between the Company and BMS, and shall
govern any and all information disclosed by either Party to the other pursuant
thereto and shall be retroactively effective to the date of such confidentiality
agreement.
-29-
Section 9.02. Use of Information.
Each Party shall use, and cause each of its Affiliates to use,
any Confidential Information obtained by it from the other Party or their
respective Affiliates, pursuant to this Agreement or otherwise, solely in
connection with the transactions contemplated hereby. The Company may use any
chemistry, manufacturing and controls information and any information set forth
in any registration dossier held by BMS relating to any Product for the purpose
of enabling and assisting the Company to commence manufacturing any such
Product.
Section 9.03. Acquired Assets.
Notwithstanding anything contained herein, except as may
otherwise be provided in the Asset Purchase Agreement, the Acquired Assets shall
be deemed the Company's Confidential Information and accordingly, shall not be
subject to any confidential treatment by the Company, but shall be subject to
confidential treatment by BMS in accordance with the terms hereof.
Section 9.04. Relief.
Each Party shall be entitled, in addition to any other right or
remedy it may have, at law or in equity, to an injunction, without the posting
of any bond or other security, enjoining or restraining any other Party from any
violation or threatened violation of this Section 9.
SECTION 10.
TERMINATION
Section 10.01. Term.
This Agreement shall become effective as of the Effective Date
and shall expire, if not earlier terminated, on the earlier of (i) the date when
no Party has any further obligations or rights hereunder or (ii) upon the third
anniversary of the Effective Date (the "Term").
Section 10.02. Breach.
Failure by either Party to comply in any material respect with
any of its material obligations contained in this Agreement shall entitle the
other Party, if it is not in material default hereunder, to give to the Party in
default written notice specifying the nature of the default and requiring it to
cure such default. If such default is not cured within sixty (60) calendar days
after the receipt of such notice (or, if such default cannot be cured within
such sixty (60) day period, if the Party in default does not commence and
diligently continue substantive actions to cure such default), the notifying
Party shall be entitled, without prejudice to any of its other rights conferred
on it by this Agreement and in addition to any other remedies available to it by
law or in equity (except as provided in Section 6), to terminate this Agreement
by giving written notice to take effect immediately upon delivery of such
notice.
Section 10.03. Bankruptcy.
In the event that a Party shall have become insolvent or
bankrupt, or shall have made an assignment for the benefit of its creditors, or
there shall have been appointed a trustee or receiver of such Party for all or a
substantial part of its property, or any case or proceeding shall have been
commenced or other action taken by or against such Party (as to which, if
involuntarily commenced against such Party,
-30-
such Party would not be able to obtain dismissal within ninety (90) days after
commencement thereof) in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency, reorganization or other
similar act or Law now or hereafter in effect, then such Party shall not be
relieved in any respect of its obligations hereunder, and, in addition to any
other remedies available to it by law or in equity, the other Party may
terminate this Agreement, in whole or in part as the terminating Party may
determine, by written notice to such Party.
Section 10.04. Effect of Termination.
(a) Upon expiration or termination of the Term, BMS shall
manufacture and ship, and the Company shall purchase from BMS any quantities of
Product which has been Firm Ordered through the effective date termination. In
addition, the Company shall have the right, by giving notice to BMS of its
exercise of such right within thirty (30) days after the effective date of such
expiration or termination, to purchase from BMS (A) any additional quantities of
Product in BMS' inventory that are in finished form within thirty (30) calendar
days after such effective date of termination, at the Purchase Price as of such
date in accordance with Section 3.01; (B) any bulk drug substance inventory at
BMS' acquisition cost therefor; and (C) BMS' inventory of any materials used in
the manufacture of Product in finished form other than bulk drug substance at
BMS' acquisition cost therefor.
(b) Without limiting either Party's right to damages for any
breach of this Agreement, neither BMS nor the Company shall incur any liability
to the other by reason of the expiration or termination of the Term or this
Agreement as provided herein, whether for loss of goodwill, anticipated profits
or otherwise, and, subject to Section 10.05, BMS and the Company shall accept
all rights granted and all obligations assumed hereunder, including those in
connection with such expiration or termination in full satisfaction of any claim
resulting from such expiration or termination.
(c) Any acceptance by BMS of any Firm Order from the Company or
the sale of the Product by BMS to the Company after the delivery of notice of
termination or after the expiration or termination of the Term for such Product
shall not be construed as a renewal or extension of this Agreement or as a
waiver of termination thereof.
(d) The license granted to BMS pursuant to Section 2.13(a)
shall immediately terminate upon termination or expiration of the Term and BMS
and its Affiliates and their agents shall cease any and all use of the Company
Confidential Information relating thereto.
Section 10.05. Accrued Rights, Surviving Obligations.
(a) Termination, relinquishment or expiration of the Term or of
this Agreement for any reason shall be without prejudice to any rights which
shall have accrued to the benefit of either Party prior to such termination,
relinquishment or expiration, and such termination, relinquishment or expiration
shall not relieve either Party from obligations which are expressly indicated to
survive termination or expiration of the Term or of this Agreement.
-31-
(b) Without limiting Section 10.05(a), termination,
relinquishment or expiration of this Agreement, in whole or in part, shall not
terminate the Company's obligation to pay the Purchase Price for, and BMS'
obligation to supply, Product which has been sold to the Company or Product
which has been ordered by Firm Order prior to the effective date of termination.
All the Parties' rights and obligations under Sections 4, 5, 6, 7, 8, 9, 12, 13
and 14, Sections 2.13(b), 3.01(b) and this Section 10.05 (as applicable) shall
survive termination or expiration hereof.
SECTION 11.
FORCE MAJEURE
Any delays in performance by any Party under this Agreement
shall not be considered a breach of this Agreement if and to the extent caused
by occurrences beyond the reasonable control of the Party affected, including
acts of God, embargoes, governmental restrictions, inability to obtain material,
fire, flood, earthquake, hurricanes, storms, tornadoes, explosion, riots, wars,
civil disorder, failure of public utilities or common carriers, labor
disturbances, rebellion or sabotage (each, a "Force Majeure Event"). The Party
suffering the occurrence of a Force Majeure Event shall immediately notify the
other Party as soon as practicable of such inability and of the period for which
such inability is expected to continue, and any time for performance hereunder
shall be extended by the actual time of delay caused by such Force Majeure
Event, provided, that, the Party suffering such Force Majeure Event uses
commercially reasonable efforts to mitigate any such delay. The Party giving
such notice shall thereupon be excused from such of its obligations under this
Agreement as it is thereby disabled from performing, and shall have no liability
for such non-performance, for so long as it is so disabled and the thirty (30)
calendar days thereafter. Where a Force Majeure Event is reasonably foreseeable,
the Party affected by the event shall use commercially reasonable efforts to
mitigate or prevent the effects of such foreseeable Force Majeure Event in light
of the nature of the Force Majeure Event and the amount of time reasonably
available to it to prepare for same.
In the event of BMS' inability to supply the Company due to a
Force Majeure Event, the Company shall have the right to obtain its supply of
the Product from an alternate supplier and, in the event a Force Majeure Event
prevents BMS' performance under this Agreement for ninety (90) consecutive
calendar days, the Company may terminate this Agreement immediately upon written
notice to BMS; provided that in such event, the Company: (a) shall purchase from
BMS any additional quantities of Product in BMS' inventory that are in finished
form and meet the minimum shelf life requirements set forth in Section
5.02(a)(v), within thirty (30) calendar days after the effective date of such
termination, at the Purchase Price as of such date in accordance with Section
3.01; (b) shall purchase from BMS BMS' inventory of any materials used in the
manufacture of Product in finished form other than bulk drug substance at BMS'
acquisition cost therefor, as indicated by supporting documentation reasonably
satisfactory to the Company; and (c) shall have the right, by giving notice to
BMS of its exercise of such right within thirty (30) days after the effective
date of such termination, to purchase from BMS any bulk drug substance inventory
at BMS' acquisition cost therefor, as indicated by supporting documentation
reasonably satisfactory to the Company.
-32-
SECTION 12.
TECHNICAL ASSISTANCE
Section 12.01. Technical Assistance.
(a) During the Term and the six (6) month period immediately following
the expiration or termination of this Agreement, upon request of the Company,
BMS shall provide the Company (and/or the Company's designee), at Company's
expense, with the assistance of its employees and access to its other internal
resources to provide the Company with a reasonable level of technical assistance
and consultation in connection with the transfer of the Product to, and
regulatory qualification of, a finished goods supplier of the Company's
election.
(b) Promptly after termination or expiration of the Term, BMS shall
provide the Company (and/or the Company's designee) with copies of all standard
operating procedures, technology, documents, data, or other information that
constitutes BMS Manufacturing Know-How, including (i) all Manufacturing Know-How
that constitutes the Acquired Assets but that was not previously provided to the
Company pursuant to the Asset Purchase Agreement; and (ii) all BMS Manufacturing
Know-How that was not previously provided to the Company pursuant to the License
Agreement. Following termination or expiration of the Term, BMS and its
Affiliates shall not use any Manufacturing Know-How other than BMS Manufacturing
Know-How, for any purpose, and shall keep it confidential to the extent required
by Section 9. With respect to all documents, data and other information provided
in accordance with the preceding sentence; (i) BMS shall be responsible for the
cost of providing a reasonable number of sets of copies only; and (ii) in
addition to paper and other tangible copies, BMS shall, upon the Company's
request, also provide to the Company electronic copies of such documents, data
and other information, provided, that, BMS or its Affiliates have electronic
copies thereof, and provided, further, that BMS shall have no obligation to
reformat or otherwise alter or modify any such materials in order to provide
them to the Company (or the Company's designee).
(c) Any Third Party manufacturer the Company may designate to
manufacture the Product shall be required to sign a customary and appropriate
confidentiality agreement with BMS with respect to the nondisclosure and use of
any Manufacturing Know-How that constitutes BMS Know-How.
(d) During the six (6) month period referred to in Section 12.01(a),
BMS shall be obligated to provide up to one hundred twenty (120) man-hours of
on-site consulting advice (including travel time) at the facilities of the
Company or its designees with respect to manufacturing sites and the conduct of
tests, studies and assays required for the transfer of manufacturing of the
Product to the Company or its designee at BMS' Fully-Burdened Cost plus 15%. BMS
and the Company shall negotiate in good faith a separate fee to be paid by the
Company to BMS in the event additional man-hours of such consulting advice is
required by the Company or its designee.
SECTION 13.
NOTICES
All notices and other communications required or permitted to be given
under this Agreement shall be in writing and shall be delivered personally or
sent by (a) registered or certified mail, return receipt requested; (b) a
nationally recognized courier service guaranteeing next-day delivery, charges
prepaid; or (c) facsimile (with original promptly sent by any of the foregoing
manners). Any
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such notices shall be addressed to the receiving Party at such Party's address
set forth below, or at such other address as may from time to time be furnished
by similar notice by either Party:
(a) if to BMS, to:
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxxxxxx, XX 00000-0000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Vice President and Senior Counsel, Pharmaceutical
Research Institute and External Development
With a copy to:
Xxxx Xxxxx LLP
Princeton Xxxxxxxxx Village
000 Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Attention: Xxxxx X. Xxxxxxx, Esq.
(b) if to the Company, to:
Women First HealthCare, Inc.
00000 Xx Xxxxxx Xxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
Attention: Xxxxxx X. Xxxxxx, President and CEO
with a copy to:
Xxxxxx & Xxxxxxx
00000 Xxxx Xxxxx Xxxxx, Xxxxx 000
Xxx Xxxxx, XX 00000
Facsimile: (000) 000-0000
Telephone: (000) 000-0000
Attention: Xxxxx X. Xxxxx, Esq.
All notices shall be effective upon such personal delivery or delivery to
such courier, upon transmission by facsimile, or three (3) days after it is sent
by such registered or certified mail, as the case may be. Copies shall be sent
in the same manner as originals.
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SECTION 14.
MISCELLANEOUS PROVISIONS
Section 14.01. Assignment.
Except as expressly permitted by Section 2.06 of this Agreement,
neither Party shall assign or otherwise transfer this Agreement or any interest
herein or right hereunder without the prior written consent of the other Party,
and any such purported assignment, transfer or attempt to assign or transfer any
interest herein or right hereunder shall be void and of no effect; provided,
however, each Party (i) may assign its rights and obligations hereunder to one
of its Affiliates without the prior consent of the other Party (although, in
such event, the assigning Party shall remain primarily responsible for all of
its obligations and agreements set forth herein, notwithstanding such
assignment); and (ii) may assign its rights and obligations to a successor
(whether by merger, consolidation, reorganization or other similar event) or
purchaser of the Facilities and/or all or substantially all its business assets
relating to the Product, provided, that, such successor or purchaser has agreed
in writing to assume all such Party's rights and obligations hereunder and a
copy of such assumption is provided to the other Party. Notwithstanding the
foregoing, Company may pledge and grant a security interest in any of Company's
rights and interests in the Product, including under this Agreement.
Section 14.02. Non-Waiver.
Any failure on the part of a Party to enforce at any time or for any
period of time any of the provisions of this Agreement shall not be deemed or
construed to be a waiver of such provisions or of any right of such Party
thereafter to enforce each and every such provision on any succeeding occasion
or breach thereof.
Section 14.03. Dispute Resolution.
The Parties recognize that a bona fide dispute as to certain matters
may from time to time arise during the Term which relates to either Party's
rights and/or obligations hereunder. In the event of the occurrence of such a
dispute, either Party may, by notice to the other Party, have such dispute
referred to their respective officers designated below, or their successors, for
attempted resolution by good faith negotiations within thirty (30) days after
such notice is received. Such designated officers are as follows:
For the Company: Xxxxxx X. Xxxxxx, President and CEO
For BMS: Xxxxxxx Xxxxxxx, Vice President and Senior Counsel,
Pharmaceutical Research Institute and External Development
In the event the designated officers are not able to resolve such
dispute within such thirty (30) day period, or such other period of time as the
Parties may mutually agree in writing, the Parties agree to have the dispute
finally settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association. The arbitration shall be governed
by the United States Arbitration Act, 9 U.S.C.(S)(S) 1-16, 201-208. The
arbitration shall be held in New York City. The arbitration proceedings shall be
conducted, and the award shall be rendered, in the English language. Each Party
shall select one arbitrator who shall be an experienced lawyer and fluent in
English. The two arbitrators appointed by the Parties shall select a third
arbitrator from among arbitrators designated by the American Arbitration
Association.
-35-
Section 14.04. Entire Agreement.
This Agreement, the Related Instruments and the Schedules and Exhibits
hereto and thereto, contain the entire agreement and understanding between the
Parties hereto with respect to the subject matter hereof and supersede all prior
agreements and understandings relating to such subject matter.
Section 14.05. Public Announcements.
The form and content of any public announcement to be made by one (1)
Party regarding this Agreement, or the subject matter contained herein, shall be
subject to the prior written consent of the other Party (which consent may not
be unreasonably withheld), except as may be required by applicable Laws
(including disclosure requirements of the SEC, NYSE, or any stock exchange) in
which event the other Party shall use commercially reasonable efforts to give
the other Party reasonable advance notice and reasonable opportunity to review
any such disclosure.
Section 14.06. Governing Law.
THIS AGREEMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH
THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO
BE PERFORMED ENTIRELY WITHIN SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW
PRINCIPLES OF SUCH STATE.
Section 14.07. Relationship of the Parties.
In making and performing this Agreement, the Parties are acting, and
intend to be treated, as independent entities and nothing contained in this
Agreement shall be construed or implied to create an agency, partnership, joint
venture, or employer and employee relationship between BMS and the Company.
Except as otherwise provided herein, neither Party may make any representation,
warranty or commitment, whether express or implied, on behalf of or incur any
charges or expenses for or in the name of the other Party. No Party shall be
liable for the act of any other Party unless such act is expressly authorized in
writing by both Parties hereto.
Section 14.08. Counterparts.
This Agreement may be executed in one (1) or more counterparts, all of
which shall be considered one (1) and the same agreement, and shall become
effective when one (1) or more such counterparts have been signed by each of the
Parties and delivered to the other Party.
Section 14.09. Severability.
In the event that any one (1) or more of the provisions contained
herein, or the application thereof in any circumstances, is held invalid,
illegal or unenforceable in any respect for any reason, the Parties shall
negotiate in good faith with a view to the substitution therefor of a suitable
and equitable solution in order to carry out, so far as may be valid and
enforceable, the intent and purpose of such invalid provision; provided,
however, that the validity, legality and enforceability of any such provision in
every other respect and of the remaining provisions contained herein shall not
be in any way
-36-
impaired thereby, it being intended that all of the rights and privileges of the
Parties hereto shall be enforceable to the fullest extent permitted by law.
Section 14.10. Expenses.
Each of BMS and the Company shall bear its own direct and indirect
expenses incurred in connection with the negotiation and preparation of this
Agreement and, except as set forth in this Agreement, the performance of the
obligations contemplated hereby and thereby.
Section 14.11. Descriptive Headings.
The descriptive headings herein are inserted for convenience only and
are not intended to be part of or to affect the meaning or interpretation of
this Agreement.
Section 14.12. Amendments and Waivers.
This Agreement may not be amended except by an instrument in writing
signed on behalf of each of the Parties. By an instrument in writing
either Party may waive compliance by the other Party with any term or provision
of this Agreement that such other Party was or is obligated to comply with or
perform. No delay or failure on the part of any Party hereto in exercising any
right, power, or privilege under this Agreement shall impair such right, power
or privilege or be construed as a waiver of any default or any acquiescence
therein. No single or partial exercise of any such right, power or privilege
shall preclude the further exercise of such right, power or privilege, or the
exercise of any other right, power or privilege.
Section 14.13. Specific Performance.
The Parties hereto agree that if any of the provisions of this
Agreement were not performed in accordance with their specific terms or were
otherwise breached, irreparable damage would occur, no adequate remedy at law
would exist and damages would be difficult to determine, and that the Parties
shall be entitled to specific performance of the terms hereof, in addition to
any other remedy at law or equity.
Section 14.14. Successors and Assigns.
This Agreement shall be binding upon and inure solely to the benefit
of the Parties hereto, their successors and permitted assigns, and nothing in
this Agreement, express or implied, is intended to or shall confer upon any
other Person or Persons any right, benefits or remedies of any nature whatsoever
under or by reason of this Agreement.
Section 14.15. Waiver of Jury Trial.
EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY
APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT TO ANY
LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH
THIS AGREEMENT OR ANY RELATED INSTRUMENT. EACH PARTY HERETO (A) CERTIFIES THAT
NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED,
EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF
LITIGATION, SEEK TO ENFORCE THAT FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT
AND THE OTHER
-37-
PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT AND THE RELATED
INSTRUMENTS, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND
CERTIFICATIONS IN THIS SECTION 14.15.
[The remainder of this page has been left blank intentionally.]
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IN WITNESS WHEREOF, each of the Parties has caused this Supply Agreement
for the Product to be executed in multiple counterparts by its duly authorized
representative.
XXXXXXX-XXXXX SQUIBB COMPANY
By: /s/ Xxxxxx X. Xxxxx, Xx.
-------------------------------------------------
Name: Xxxxxx X. Xxxxx, Xx.
Title: Vice President, Corporate Development
WOMEN FIRST HEALTHCARE, INC.
By: /s/ Xxxxxxx X. Xxxxxxxx
-------------------------------------------------
Name: Xxxxxxx X. Xxxxxxxx
Title: Chief Financial Officer
SCHEDULE 1.01
-------------
PRODUCT INFORMATION
PRODUCT SKU# ASSOCIATED TRADEMARKS SHELF LIFE
------- -------- --------------------- ----------
VANIQA(R) 30g 150030 VANIQA(R) 24 Months
VANIQA(R) 60g dual pack 150060 VANIQA(R) 24 Months
VANIQA(R) 2g sample 150092 VANIQA(R) 12 Months
VANIQA(R) 30g physician sample 150095 VANIQA(R) 24 Months
SCHEDULE 2.03(a)
----------------
INITIAL FIRM ORDER FOR MONTHS 1 TO 6 AFTER EFFECTIVE DATE
150060-60g 150092-2g 150095-30g
150030-30g Twin Pack sample physician sample
---------- --------- --------- ----------------
July
August [***]
September
October [***]
November
December
Total [***] [***] [***] [***]
*** 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.
SCHEDULE 2.04
-------------
FORM OF CERTIFICATE OF ANALYSIS
SCHEDULE 3.01(a)
----------------
INITIAL PURCHASE PRICE AND BATCH SIZE
Initial Purchase Minimum Batch Minimum Batch
SKU# Price (in U.S. Dollars) Size Tubes Size Package
---- ----------------------- ----------------- -------------
150030-30g [***] 64,704 2,696 cases
(1x24)
150060-60g [***] 31,800 dual packs 2,650 cases
dual pack (or 63,600 tubes) (1x12)
150092- [***] 917,424 6,371 cases
2g sample (1x144)
150095-30g [***] 63,384 2,641 cases
physician sample (1x24)
*** 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.
SCHEDULE 3.01(b)
----------------
VARIABLE PRODUCT COSTS
Variable Product Costs
Product (in U.S. Dollars) SKU#
------- ---------------------- --------
VANIQA(R) 30g (24 units) [***] 150030
VANIQA(R) 60g dual pack (12 units) [***] 150060
VANIQA(R) 2g sample (144 units) [***] 150092
VANIQA(R) 30g physician sample (24 units) [***] 150095
*** 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.
