Exhibit 10.5
MANUFACTURING AND SUPPLY AGREEMENT
This Manufacturing And Supply Agreement (this "AGREEMENT"),
effective as of
July 28, 2004 (the "EFFECTIVE DATE"), is made by and between Chiron
Corporation,
a Delaware corporation with offices at 4560 Horton Street,
Emeryville,
California 94608 ("CHIRON"), and BioMimetic Pharmaceuticals, Inc.,
a Delaware
corporation with offices at 330 Mallory Station, Suite A-l,
Franklin, Tennessee
37067 ("BMPI").
BACKGROUND
BMPI and Chiron are parties to an exclusive, Clinical Manufacturing
Supply
Agreement effective March 28, 2001, under which Chiron has
manufactured and
supplied BMPI with purified bulk recombinant human platelet derived
growth
factor (PDGF), as described in Chiron's FDA-approved Biological
License
Application therefor ("CHIRON'S BLA"), for use in product
development and
clinical testing and in the Fields (as defined below). That
agreement provides
that, not less than one year prior to the commencement of
commercial sales of
products containing purified bulk recombinant human platelet
derived growth
factor, the parties shall negotiate a commercial manufacturing
agreement on
certain terms specified therein and other commercially reasonable
terms. The
parties have now completed negotiations and hereby agree to the
terms and
conditions set forth herein, including Exhibit A and B, which are
attached
hereto and incorporated herein, by reference. (Specific sections of
Exhibit A
are cited hereinafter as "A-l," "A-2", etc. In the event of any
conflict between
Exhibit A and this Agreement, this Agreement shall be controlling.)
AGREEMENT
1.
DEFINITIONS. For purposes of this Agreement, the following
definitions
shall apply, and the terms defined herein in plural shall include
the
singular and vice-versa.
1.1. "Affiliate" means any corporation or other entity that
controls, is
controlled by or is under common control with Chiron, BMPI or
Novartis
AG, as applicable, as of the Effective Date or during the term of
this
Agreement. "Control" means the ownership, directly or indirectly,
of
50% or more of the voting stock of a corporate entity, or of 50% or
more of the beneficial interest of an entity other than a
corporation.
Notwithstanding the foregoing, "Affiliates" of Chiron exclude
Novartis
AG, a Swiss corporation, and any Affiliates thereof, regardless of
the
percentage of ownership interest that Novartis AG may hold in
Chiron,
unless and until such time as Novartis AG exercises its rights to
control Chiron in accordance with the terms and conditions of the
November 20, 1994 Governance Agreement between them.
1.2. "Approval Date" has the meaning given in Section 4.4.
1.3. "cGMPs" means the then-current Good Manufacturing Practices
applicable
to the manufacture, processing, packaging, testing and release of
bulk
pharmaceutical products for human use, established by regulatory
authorities of the United States, Canada and the European Union, as
applicable.
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1.4. "Changed Services" has the meaning given in Section 2.3.
1.5. "Chiron's BLA" has the meaning given in the first paragraph,
above.
1.6. "Claims" has the meaning given in Section 8.3.
1.7. "Confidential Information" has the meaning given in Section
7.1.
1.8. "Conforming" or "Conformity," (a) in reference to Product,
means
Product that is shown, solely by the related written Deliverables,
to
have been manufactured in accordance with applicable cGMPs and the
Procedures, to meet the Specifications, and to have a remaining
shelf life, at the time of delivery to BMPI's designated carrier,
of
not less than eighteen (18) months, and (b) in reference to other
Deliverables, means Deliverables conforming to all criteria
established for them herein.
1.9. "Deliverables" means Product and the other items identified in
A-5.
1.10. "FDA" means the U.S. Food And Drug Administration.
1.11. "Facilities" means Chiron's licensed biological production
facilities
located in Vacaville and Emeryville, California, and its warehouses
located in Emeryville, California.
1.12. "Fields" means the treatment of periodontal and dental
diseases,
craniomaxillofacial applications and other skeletal applications
including the healing of bone, cartilage, tendon and ligaments of
the
skeletal systems in humans and animals.
1.13. "Nonconforming" or "Nonconformity," with respect to
Deliverables,
means Deliverables that are not Conforming.
1.14. "Notice Period" has the meaning given in Section 11.1.
1.15. "Product" means Saccharomyces derived cGMP purified bulk
recombinant
human platelet derived growth factor, **, as specified in Chiron's
BLA.
1.16. "Procedures" means those procedures identified in A-3.
1.17. "Specifications" means the assay specifications set forth in
the
relevant certificate of analysis of the Product, as further
described
A-8.
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**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
2.
PRODUCT MANUFACTURE, SUPPLY AND USE.
2.1. Product Supply And Purchase. During the term of this
Agreement, Chiron
shall manufacture and supply exclusively to BMPI, and BMPI shall
purchase exclusively from Chiron, Product for use in the Fields.
Forecasting requirements, and minimum and maximum quantities of
Product to be purchased and supplied, are provided in A-6 and A-7,
respectively.
2.2. Use Restrictions. BMPI understands and acknowledges that
Chiron's
rights to supply Product are derived in part from third-party
licenses
that restrict the uses of Product; accordingly, BMPI agrees not to
use, sell or import Product, or to make, use, sell or import any
product incorporating Product, other than in the Fields.
2.3. Changed Services. If material additions to or changes in the
services
to be provided hereunder are required ("CHANGED SERVICES"), to the
extent practicable and subject to the change control procedures set
forth in A-1 and A-3, Chiron shall prepare a written statement that
describes in detail the proposed Changed Services and anticipated
changes in costs resulting therefrom and provides such other
information as BMPI may reasonably require. BMPI's written consent
to
Changed Services shall subject the accepted Changed Services to all
provisions of this Agreement, other than any that such consent
expressly supersedes.
3.
DELIVERY, INSPECTION, ACCEPTANCE AND REJECTION.
3.1. Delivery. Chiron shall make Product and related Deliveries
available
to BMPI's designated shipper within ** days of receipt of a binding
purchase order from BMPI. All shipments shall be EXW (Incoterms
2000)
the Emeryville Facility.
3.2. Acceptance And Rejection. BMPI shall have ** business days
from the
date of receipt of Deliverables to determine whether they are
Confirming. Such determination shall be made solely based on the
written Deliverables and not on assays or other tests of the
Product.
BMPI shall promptly notify Chiron, in writing, of any Nonconforming
Deliverables and the specific reasons for such Nonconformity.
Failure
to reject Deliverables within such ** business day period shall be
deemed acceptance of the Deliverables.
3.3. Disputes Re Conformity. If BMPI notifies Chiron of any alleged
Nonconformity of Deliverables, the invoice for such Deliverables
shall
not be due or payable until the Nonconformity issue is resolved,
and
BMPI has accepted such Deliverables or replacement Deliverables.
The
parties shall in good faith attempt to resolve the issue within **
days of BMPI's notice, and if unable to do so, shall follow the
Dispute Resolution process set forth in Section 13.9.
3.4. Exclusive Remedy. If any Deliverables received by BMPI are
Nonconforming, Chiron, shall replace the Nonconforming Deliverables
as
soon as is reasonably commercially practicable, at no additional
charge to BMPI. Such replacement shall be Chiron's sole liability
and
BMPI's sole remedy with respect to Nonconforming Deliverables.
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**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
4.
COMPENSATION.
4.1. Product Pricing. BMPI will pay Chiron the amounts set forth in
A-7, at
the times specified therein.
4.2. Taxes. Prices and fees do not include any national, state or
local
sales, use, value-added or other taxes, customs duties, or similar
tariffs or fees that Chiron may be required to pay or collect upon
the
delivery of Deliverables hereunder or upon collection of the prices
and fees or otherwise. Should any tax or levy be made (other than
any
such tax based on the income of Chiron), BMPI agrees to pay such
tax
or levy and to indemnify Chiron for any claim for such tax or levy
demanded, including applicable penalties and interest, other than
to
the extent (if any) due to Chiron's failure to comply with its
obligations to collect or to remit such tax. BMPI agrees to provide
Chiron with appropriate resale certificate numbers and other
documentation satisfactory to the applicable taxing authorities to
substantiate any claim of exemption from any such taxes or fees.
4.3. Third Party Royalties. BMPI shall reimburse Chiron for all
royalties
that Chiron is required to pay to third parties, in order to
manufacture and supply Product to BMPI, including the royalties
described in A-7.2. If either party is put on notice by a third
party
of alleged infringement by Chiron in the manufacture of Product,
such
party shall promptly inform the other party thereof. BMPI shall
promptly resolve any matter relating to such alleged infringement
and
shall timely pay all amounts due resulting from or relating to the
manufacture of Product or the commercial sale of any product
incorporating Product. These payments shall be in addition to the
compensation provided in A-7.
4.4. Milestone Fees. Subject to Article 5, within thirty (30) days
of the
date of issuance by the U.S. Food And Drug Administration of the
first
approval to market a product containing Product (the "APPROVAL
DATE"),
and each year thereafter for a period of three (3) years, BMPI
shall
pay Chiron a milestone fee of **.
4.5. Payments. All payments shall be made in United States Dollars
by wire
transfer of immediately available funds to an account as specified
by
Chiron in writing from time to time. If any payment due hereunder
is
not paid in full on the due date, interest at the prime rate (as
announced from time to time by Bank of America NT & SA) plus
two
percent, or the maximum permitted by law, whichever is lower, shall
accrue and become payable upon any unpaid balance from the date
such
payment was due until it is paid in full.
5.
LOAN OPTION. BMPI may opt to take a loan from Chiron on the terms
and
conditions provided in Exhibit B hereto.
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**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
6.
QUALITY AND REGULATOR MATTERS.
6.1. Right to Review Processes. Chiron shall maintain all quality
assurance
manufacturing records, batch production records and other records
directly related to Product manufacture, as required by applicable
regulations. BMPI personnel shall have the right to review such
records at the Facilities during regular business hours and upon at
least ** days advance written request to Chiron's Corporate
Regulatory
Compliance Group, for the sole purpose of auditing Chiron's
compliance
with cGMPs and the Procedures in manufacturing Product; provided,
however, that Chiron may delay such inspection for a period of up
to
** days if, in its good faith judgment, such delay is necessary to
avoid a significant disruption in Chiron's business. In the event
that
a regulatory inspection occurs during a time schedule for a BMPI
audit, Chiron may reschedule the audit to a date within ** days of
the
originally-scheduled audit. Each BMPI audit shall be completed
within
three (3) days and shall be conducted by no more than three
reviewers,
who shall comply with all reasonable Chiron policies and procedures
regarding the Facilities. BMPI shall be entitled to one such audit
per
year during the term of this Agreement and one during the year
following expiration or termination of this Agreement, at no
charge.
Chiron shall respond to all audit findings, in writing, within **
days
of receipt or as otherwise agreed by the parties, in writing. All
information obtained by BMPI pursuant to this Section 6.1 shall be
subject to the confidentiality provisions of Article 7.
6.2. Product Complaints. Subject to Subject 8.3, BMPI shall be
responsible
for handling all complaints regarding products that incorporate
Product. Chiron will promptly forward any such complaints it
receives
to BMPI and will provide, at BMPI's expense, such assistance in
investigating such complaints as BMPI may reasonably request.
Should
such investigation show that the complaint was a result of Product
manufacturing under the control of Chiron, expenses owed or paid
pursuant to this Section 6.2 for Chiron's assistance shall be
cancelled or refunded to BMPI. The parties shall in good faith
freely
exchange information that will enable them to determine the nature
and
cause of such complaints. BMPI shall have the authority to resolve
any
outstanding complaints. BMPI shall promptly notify Chiron if such a
complaint is based upon an alleged defect in the manufacture of
Product.
6.3. Recalls. The handling of recalls and withdrawals of products
incorporating Product shall be within the sole discretion of BMPI.
Chiron will cooperate fully with BMPI in the event of any such
recall
or withdrawal and will provide, at BMPI's expense, such assistance
in
connection therewith as BMPI may reasonably request. Should an
investigation establish that the product defect or other problem
that
gave rise to the recall or withdrawal arose out of the manufacture
of
Product by Chiron, any expenses owned or paid to Chiron pursuant to
this Section 6.3 shall be cancelled or refunded to BMPI, as
applicable.
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**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
6.4. U.S. Cross-Reference Rights.**
6.5. European Cross-Reference Rights.**
6.6. Safety and Waste Handling Procedures. Chiron shall be
responsible for
maintaining safety and environmental procedures that comply with
all
material applicable laws.
6.7. Quality Agreement. As soon as reasonably practicable, the
parties
shall execute an appropriate quality assurance agreement to fulfill
applicable legal and regulatory requirements.
7.
CONFIDENTIAL INFORMATION.
7.1. Definition. During the term of this Agreement, the parties may
provide
to one another confidential information, including but not limited
to
each party's proprietory materials and/or technologies, economic
information, business or research strategies, trade secrets and
material embodiments thereof. As used herein. "CONFIDENTIAL
INFORMATION" of a party means any information disclosed by such
party
to the other party which (a) if in written form, is clearly marked
"confidential," (b) if in oral form, is summarized in a writing
marked
"confidential" delivered to the recipient within thirty (30) days
after the oral disclosure, (c) if further disclosed, could
reasonably
be expected to result in competitive harm to the disclosing party,
or
(d) consists of or relates to any unpublished patent application.
7.2. Exclusions. Confidential Information shall not include
information
that (a) is shown by contemporaneous documentation of the recipient
to
have been in its possession prior to receipt from the disclosing
party, (b) is or becomes, through no fault of the recipient,
publicly
known, (c) is furnished to the recipient by a third party without
breach of an obligation of confidentiality, (d) is independently
developed by the recipient without use of the disclosing party's
Confidential Information or (e) is required to be disclosed by law,
provided that the recipient gives the disclosing party as much
advance
notice of the requirement as is reasonably possible to give.
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**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
7.3. Obligations. During the term of this Agreement and for five
(5) years
thereafter, the recipient shall maintain the disclosing party's
Confidential Information in confidence, except that BMPI may
disclose
this Agreement in its entirety to parties evaluating a business
relationship with BMPI, provided that such parties are under
written
obligations of confidentiality and non-use with respect to this
Agreement at least as restrictive as those set forth herein with
respect to Chiron's Confidential Information. The recipient shall
use
the disclosing party's Confidential Information solely to exercise
its
rights and perform its obligations under this Agreement, unless
otherwise mutually agreed in writing, and shall at all times
protect
the disclosing party's Confidential Information with at least the
same
degree of care it uses to protect its own Confidential Information,
such care to be of the type and degree that would be used by a
reasonable and prudent business person. The recipient acknowledges
that breach of confidentiality may result in irreparable financial
harm to the disclosing party and that the disclosing party may seek
all remedies in law or equity for such a breach.
7.4. Return of Confidential Information. Upon request by the
disclosing
party, the recipient shall return or destroy (as evidenced by a
written certificate of destruction) all Confidential Information of
the disclosing party in its possession; provided, however, that one
copy of such Confidential Information may be retained in the
recipient's legal files for purposes of monitoring compliance with
the
provisions hereof.
8.
INSURANCE; INDEMNITY; LIMITATIONS ON LIABILITY.
8.1. Insurance of Chiron. Chiron shall procure and maintain in full
force
and effect, at its own cost and expense, insurance against the
risks
arising hereunder as follows:
(a) products liability, with annual liability limits of not less
than
$5,000,000 per claim and in the aggregate,
(b) general liability, with annual liability limits of not less
than
$5,000,000 per claim and in the aggregate,
(c) Worker's compensation insurance in compliance with the worker's
compensation laws of the state or states in which Chiron has
employees
performing work under this Agreement, and employer's liability
insurance with respect to such employees, with a minimum limit of
One Million Dollars ($1,000,000) per occurrence, and
(d) motor vehicle insurance for vehicles owned, leased or operated
by
Chiron or its employees or agents performing work under this
Agreement, with a minimum limit of One Million Dollars ($1,000,000)
per occurrence, combined single limit.
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8.2. BMPI Insurance. BMPI shall procure and maintain in full force
and
effect, at is own cost and expense, products liability insurance,
with
annual liability limits of not less than $5,000,000 per claim and
in
the aggregate, and comprehensive general liability insurance, with
annual liability limits of not less than $5,000,000 million per
claim
and in the aggregate. Terms of such coverage shall be evidenced by
certificates of insurance to be furnished to Chiron within 30 days
of
the Effective Date and as may be reasonably requested thereafter.
Such
certificates shall name Chiron, its Affiliates and their respective
agents, employees and directors as additional insureds and shall
provide that thirty (30) days' written notice shall be given to
Chiron
prior to cancellation or expiration of any of the terms of coverage
or
any policy.
8.3. Indemnification. BMPI shall indemnify and hold Chiron, its
Affiliates
and their respective directors, officers, employees and agents,
harmless against all claims, damages, liabilities, losses, costs
and
expenses, including reasonable attorneys' fees (collectively,
"CLAIMS"), to the extent arising from (a) the manufacture, use or
sale
of any deliverable hereunder or of any product incorporating
Product,
including but not limited to any such Claim for product liability
(whether based on strict liability, inherent design defect,
negligence, failure to warn, breach of contract or any other theory
of
liability) or (b) any act or omissions of BMPI or any of its
directors, officers, employees or agents, and from any Claim
alleging
that the manufacture, use or sale of any Deliverable, or product
incorporating Product infringes any intellectual property rights of
a
third party.
8.4. Limitation on Damages. EXCEPT WITH RESPECT TO SECTION 8.3, IN
NO EVENT
SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY, ITS AFFILIATES OR
ANY
THIRD PARTY FOR LOST PROFITS OR FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, PUNITIVE OR INDIRECT DAMAGES ARISING FROM A BREACH OF
THIS
AGREEMENT, INCLUDING WITHOUT LIMITATION ANY BREACH OF A WARRANTY
CONTAINED HEREIN OR OF ANY OBLIGATION TO PERFORM SERVICES OR TO
PROVIDE DELIVERABLES BY A SPECIFIED TIME.
9.
REPRESENTATIONS AND WARRANTIES.
9.1. Of Chiron. Chiron warrants that (a) at the time of delivery to
BMPI's
designated carrier, Deliverables will be Conforming and (b) as of
the
Effective Date, to the best of Chiron's knowledge, there are no
legal
actions pending or threatened to be filed against Chiron that would
prevent the manufacture or commercial sale of Product, as
contemplated
hereunder.
9.2. Of Each Party. Each party represents and warrants to the other
party
that (a) such party has full power and authority to execute and
deliver this Agreement and to perform its obligations hereunder,
(b)
the execution, delivery and performance by such party of this
Agreement has been duly and validly authorized, and no additional
authorization or consent is required in connection with the
execution,
delivery and performance by such party of this Agreement and (c)
this
Agreement has been duly executed and delivered by such party and
constitutes a valid and legally binding obligation of such party,
enforceable in accordance with its terms.
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9.3. No Other Warranties. EXCEPT FOR THE WARRANTIES PROVIDED IN
THIS
ARTICLE 9, CHIRON MAKES NO WARRANTY, EXPRESS OR IMPLIED, REGARDING
THE
DELIVERABLES, INCLUDING WITHOUT LIMITATION ANY WARRANTY REGARDING
THEIR FITNESS FOR ANY PURPOSE, THEIR QUALITY, THEIR MERCHANTABILITY
OR
THEIR NON-INFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES. ANY REPRESENTATIONS OR WARRANTIES MADE BY ANY PERSON OR
ENTITY, INCLUDING EMPLOYEES OR REPRESENTATIVES OF CHIRON, THAT ARE
INCONSISTENT HEREWITH, SHALL BE DISREGARDED AND SHALL NOT BE
BINDING
ON CHIRON.
10.
TERM AND TERMINATION.
10.1. Term. The term of this Agreement shall be seven (7) years
from the
Effective Date, unless sooner terminated pursuant to Section 10.2,
and
shall automatically renew thereafter for consecutive one-year
periods,
unless either party has notified the other in writing, at least two
(2) years prior to the renewal date, of its intention to terminate
the
Agreement.
10.2. Termination. This Agreement may be terminated:
10.2.1. By either party:
(a)
upon any material breach of this Agreement by the other
party; provided, however, that the party alleging such
breach must first give the other party written notice
thereof, which notice must state the nature of the breach in
reasonable detail and that the party giving such notice
views such alleged breach as a basis for terminating this
Agreement under this Section 10.2.1 (a), and the party
receiving such notice must have failed, within sixty (60)
days after receipt of such notice, (i) to cure such alleged
breach or (ii) to develop and implement a plan reasonably
acceptable to the aggrieved party to remedy the breach
within a reasonable period of time, or
(b)
if (i) the other party makes an assignment for the benefit
of its creditors or files a voluntary petition under federal
or state bankruptcy or insolvency laws, (ii) a receiver or
custodian is appointed for all or substantially all of the
other party's business, (iii) proceedings are instituted
against the other party under federal or state bankruptcy or
insolvency laws that have not been stayed or dismissed
within sixty (60) days, (iv) all or substantially all of the
other party's business or assets become subject to
attachment, garnishment or other process or (v) a court or
other governmental authority of competent jurisdiction
determines that the other party is insolvent, such early
termination to be effective immediately upon the occurrence
of the applicable event.
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10.2.2. By Chiron:
(a)
effective upon written notice to BMPI, that Chiron is in receipt
of notice from a third party that the manufacture or supply of
Product infringes a patent or other intellectual property right
of such party, unless BMPI obtains the consent of such party for
Chiron to continue to manufacture and supply Product, whether
such consent is by license or other written agreement, within
ninety (90) days of the written notice from Chiron of the alleged
infringement,
(b)
upon sixty (60) days notice to BMPI, if BMPI fails to use
commercially reasonable efforts to obtain Product marketing
approvals from regulatory authorities of the United States,
Canada and the European Union, unless BMPI demonstrates, within
such 60-day period, that it is using commercially reasonable
efforts to obtain such marketing approvals or
(c)
pursuant to Section 11.l(c).
10.2.3. By BMPI:
(a)
effective upon written notice to Chiron, subject to payment of
the fees specified in A-7,
(b)
upon 60 days written notice to Chiron that BMPI cannot obtain
commercially reasonable terms for any third-party license
required by Chiron to manufacture Product, in which case, no
compensation shall be payable to Chiron other than amounts due
and owing under any outstanding Binding Requirements and purchase
orders,
(c)
upon written notice to Chiron if Chiron has failed to deliver the
Binding Requirements of a Purchase Order (as those terms are
defined in A-6.1(C) - D)) within one hundred twenty (120) days of
the delivery date requested therein or
(d)
pursuant to Section 11.2.
10.3. Survival. Expiration or termination of this Agreement for any
reason shall
not release either party from any liability, obligation or
agreement that
has already accrued or preclude either Party from pursuing all
rights and
remedies it may have hereunder at law or in equity with respect to
any
breach of this Agreement prior to such expiration or termination.
The
provisions of Articles 5, 6, 7 and 8, and Sections 2.2, 3.3, 3.4,
4.2, 4.3,
10.3, 11.3, 13.5, 13.8 and 13.9 shall survive expiration or
termination of
this Agreement.
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11. CHIRON'S OPTION TO SUBCONTRACT, ASSIGN OR TERMINATE.
11.1. Option. Notwithstanding anything to the contrary stated
herein, if
Chiron decides to sell or otherwise transfer ownership of its
Vacaville Facility to a third party or to discontinue all
manufacture
of rhPDGF-BB, upon at least six (6) months prior written notice
("NOTICE PERIOD") to BMPI, Chiron may (a) subcontract the
manufacture
of Product hereunder to a qualified third-party, (b) assign
Chiron's
rights and obligations hereunder, to a qualified third-party
manufacturer or (c) terminate this Agreement, subject to Sections
11.2
and 11.3.
11.2. Minimum Supply Obligation. Prior to any subcontracting,
assignment
or termination pursuant to Section 11.1, Chiron shall manufacture,
for
supply to BMPI:
(a) that quantity of Product ordered during the twelve (12) month
period immediately preceding Chiron's notice multiplied by:
(i)
4, if such subcontracting, assignment or termination
becomes effective prior to the 6th anniversary of the
Effective Date, and
(ii) 3, if such subcontracting, assignment or termination
becomes effective following the 6th anniversary of the
Effective Date
(with any partial years pro-rated), provided, however, that the
total quantity of Product to be supplied shall not exceed 1,260
grams,
(b) any lesser quantities of Product requested by BMPI (but no
less than BMPI is required to purchase pursuant to A-6(C)) or
(c) such other quantities of Product upon which the parties may
agree, in writing.
BMPI shall be obligated to purchase from Chiron all Conforming
Product
so ordered, pursuant to the terms hereof, within three (3) years of
the date of Chiron's notice.
11.3 Technology Transfer. If Chiron terminates this Agreement
pursuant to
Section 11.1(c), upon request by BMPI, Chiron shall timely transfer
all Chiron technology required or useful for Product manufacture to
a
qualified third-party manufacturer selected by BMPI, provided that
such manufacturer agrees in writing to treat all such technology
and
related information as confidential, under terms at least as
restrictive as those contained herein, and to limit its use of such
technology to Product manufacture for BMPI. Chiron shall not charge
BMPI for such services; however, BMPI shall be responsible for all
third-party charges.
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12.
NOTICES. Any notice to be given hereunder shall be in writing and
shall be
deemed given when so delivered in person, by overnight courier
(with
receipt confirmed) or by facsimile transmission (with receipt
confirmed by
telephone or by automatic transmission report) or, if given by
mail, upon
receipt, as follows (or to such other persons and/or addresses as
may be
specified in writing to the other party hereto):
If to BMPI:
With a copy to:
BioMimetic Pharmaceuticals, Inc.
BioMimetic Pharmaceuticals, Inc.
330 Mallory Station, Suite A-I
330 Mallory Station, Suite A-I
Franklin, TN 37067
Franklin, TN 37067
Attention: Chairman and CEO
Attention: Executive Vice President
Facsimile: (615) 844-1281
Facsimile: (615) 844-1281
If to Chiron, to:
With a Copy to:
Chiron Corporation
Chiron Corporation
4560 Horton Street
4560 Horton Street
Emeryville, CA 94608
Emeryville, CA 94608
Attn: President, BioPharmaceuticals
Attn: General Counsel
Facsimile: (510)923-3832
Facsimile: (510)654-5360
13. MISCELLANEOUS.
13.1. Force Majeure. Failure or delay by a party in the performance
of its
obligations hereunder shall be excused to the extent that
performance
is rendered impossible by strike, fire, flood, earthquake,
windstorm,
power or utilities shortage, governmental acts, orders or
restrictions, or any other cause, to the extent that the failure to
perform is beyond the reasonable control and not caused by the
negligence or willful misconduct of the non-performing party,
provided that if such Force Majeure event extends beyond one
hundred
and twenty (120) days, the unaffected party may forthwith terminate
this Agreement.
13.2. Independent Contractors. The relationship of BMPI and Chiron
hereunder is that of independent contractors, and nothing contained
herein shall be construed (a) to give either party the power to
direct
or control the day-to-day activities of the other, (b) to
constitute
the parties as partners, joint venturers, co-owners or otherwise as
participates in a joint or common undertaking or (c) to allow a
party
to create or assume any obligation on behalf of the other party for
any purpose whatsoever.
13.3. Assignment. Other than as provided in Section 11.1(a),
neither party
may transfer or assign, whether directly or indirectly, this
Agreement
or its rights or obligations herein, without the prior written
consent
of the other party, which consent shall not be unreasonably
withheld,
except that either party may transfer or assign any of its rights
and
obligations hereunder to any Affiliate or to any corporation or a
person that acquires all or substantially all of the business or
assets of such party to which this Agreement relates or pursuant to
a
merger or consolidation. Each party shall notify the other promptly
following any such transfer, assignment, merger or consolidation.
Any
purported assignment in contravention of this Section 13.3. shall,
at
the option of the non-assigning party, be null and void. This
Agreement shall be binding upon and inure to, the benefit of the
parties hereto, their successors and permitted assigns.
12-
13.4. Waiver. No waiver of any term or condition of this Agreement
shall be
valid or binding on either party unless agreed in writing by the
party
to be charged. The failure of either party to enforce at any time
any
of the provisions of the Agreement, or the failure to require at
any
time performance by the other party of any of the provisions of
this
Agreement, shall in no way be construed to be a present or future
wavier of such provisions, nor in any way affect the validity of
either party to enforce each and every such provision thereafter.
13.5. Severability. If any provisions of this Agreement are held to
be void
or unenforceable in any particular country, then such void or
unenforceable provisions shall be
