Exhibit 10.11
SUPPLY AND DISTRIBUTION AGREEMENT: INVESTIGATIONAL PHASE
THIS AGREEMENT (the "AGREEMENT") is entered into by and between OMRIX
BIOPHARMACEUTICALS, LTD., an Israeli company (hereinafter, "OMRIX"), and FFF
ENTERPRISES, INC., a United States ("US") corporation organized and existing
under the laws of California (hereinafter, "FFF") together with Omrix, the
"PARTIES" and each individually a "PARTY," as of December 21, 2005 (the
"EFFECTIVE DATE").
WHEREAS:
A. Omrix manufactures Omrigam NF, a proprietary immune globulin intravenous
(IGIV), which has not been cleared by the United States (US) Food and Drug
Administration (FDA) for marketing in the US;
B. Omrix wishes to obtain FDA approval of a Biologics License Application
(BLA) to market Omrigam NF in the US;
C. Omrix is the sponsor of an active Investigational New Drug Application
(hereinafter "OMRIX IND") to use Omrigam NF in clinical trials of patients
with primary immune deficiency (hereinafter "CLINICAL TRIALS");
D. FFF is a wholesale distributor of pharmaceutical products, including IGIV
products, in the US and wishes to be the exclusive distributor of Omrigam
NF in the US;
E. FFF wishes to take over sponsorship of the amended Omrix IND (referred to
as the FFF IND);
F. FFF also wishes to be responsible for conducting the Clinical Trials and
Omrix will use the data collected in the Clinical Trials to prepare a
Biologics License Application ("BLA") to submit to the FDA under Omrix's
name to market Omrigam NF commercially in the US;
G. FFF wishes to distribute Omrigam NF in the US under a TREATMENT PROTOCOL,
as defined below, until the BLA is approved by the FDA;
H. FFF will conduct both the Clinical Trials and the Treatment Protocol under
the FFF IND ;
I. Omrix wishes to supply Omrigam NF exclusively to FFF for use in the
Clinical Trials and under a Treatment Protocol (collectively the
"INVESTIGATIONAL PHASE");
J. Omrix wishes to designate FFF as its exclusive authorized distributor to
market Omrigam NF in the US subsequent to FDA approval of the BLA for
Omrigam NF (the "COMMERCIAL PHASE," as defined in section 1.5, below); and
K. Simultaneous execution of the agreement between the Parties for the
Commercial Phase, SUPPLY AND DISTRIBUTION AGREEMENT: COMMERCIAL PHASE,
attached hereto as Exhibit A) is a concurrent condition to the complete
execution of this Agreement:
NOW, THEREFORE, in consideration of the mutual promises and covenants contained
herein, effective upon the Effective Date, the Parties agree as follows:
1. DEFINITIONS
As used in this Agreement the following definitions shall apply in each case
where the defined term appears in capitalized form:
1.1. "BLA" - means a Biologics License Application, as defined in 21 CFR
Section 601.2.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 1 of 27
PORTIONS OF THIS EXHIBIT MARKED BY AN *** HAVE BEEN OMITTED PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
1.2. "CFR" - means the U.S. Code of Federal Regulations, as may be amended
from time to time, and any successor thereto.
1.3. "CGMP" - means current Good Manufacturing Practices and General
Biological Products Standards as defined in 21 CFR Parts 210, 211 and
600 and 606.
1.4. "CLINICAL TRIALS" - means the Phase 2 and the Phase 3 Clinical Trials,
as defined below.
1.5. "COMMERCIAL PHASE" - means the phase of a relationship between the
Parties after FDA approval of a Biologics License Application has been
obtained and Omrigam NF may be marketed in the U.S. The agreement
between the Parties for FFF to be the exclusive distributor of Omrigam
NF for the Commercial Phase is attached hereto as Exhibit A (SUPPLY
AND DISTRIBUTION AGREEMENT: COMMERCIAL PHASE).
1.6. "DATA" - means data collected in the Clinical Trials.
1.7. "DCI" - means DCI Management Group, LLC.
1.8. "DCI CONTRACT" - means the Plasma Supply Agreement between Omrix and
DCI Management Group, LLC, attached hereto as Exhibit B, execution of
which is a condition precedent to this Agreement.
1.9. "FDA" - means the US Food and Drug Administration.
1.10. "FFF IND" -- means the Investigational New Drug Application approved
by the FDA and held by FFF for Omrigam NF. This is the amended version
of the Omrix IND
1.11. "IGIV" - means immune globulin intravenous.
1.12. "IND" - means an Investigational New Drug Application, as described
in 21 CFR Part 312.
1.13. "INSTITUTIONAL REVIEW BOARD" (IRB) - means the committee responsible
for reviewing and approving biomedical research involving human
subjects, as described in 21 CFR 50.3(i).
1.14. "INVESTIGATIONAL DRUG" - means cGMP quality Omrigam NF prior to
approval by the FDA of a Biologics License Application.
1.15. "INVESTIGATIONAL PHASE" - means the phase of the relationship between
the Parties described in this Agreement, which covers exclusive use by
FFF and its agents of Omrigam NF in Clinical Trials and exclusive
distribution by FFF of Omrigam NF under a Treatment Protocol,
providing a Treatment Protocol is approved by the FDA.
1.16. "INVESTIGATOR" - means an individual who actually conducts a clinical
investigation (i.e., under whose immediate direction the drug is
administered or dispensed to a subject), as defined in 21 CFR Section
312.3. In a team of investigators, the Investigator is the leader of
the team. A licensed practitioner who receives and dispenses the
Investigational Drug under a Treatment Protocol is an Investigator, in
accordance with 21 CFR Section 312.35(a)(3).
1.17. "MANUFACTURING SPECIFICATIONS" - means the specifications in the
Omrix IND, as amended from time to time, for compliance with cGMP
standards and specifications for the chemistry, manufacturing and
quality control, labeling, packaging and shipping of the
Investigational Drug.
1.18. "OMRIX IND" - means the Investigational New Drug Application
submitted to the FDA by Omrix in 2001 and held by Omrix for Omrigam
NF, until amended in December 2005 -- the amended IND is the FFF IND.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 2 of 27
1.19. "OMRIGAM NF" - means Omrix's proprietary polyvalent IGIV.
1.20. "OMRIX TECHNOLOGY" - means all the technical information, whether
tangible or intangible, including (without limitation) any and all
data, techniques, discoveries, inventions, processes, formulations,
know-how, patents (including any divisional, continuation, extension,
reissue, reexamination certificate, or renewal patents), patent
applications, inventor certificates, trade secrets, method of
production and other proprietary information, that Omrix has rights to
(as either owner, licensee or sublicense), or may hereafter obtain
rights to, relating to Omrigam NF.
1.21. "PHASE 2 CLINICAL TRIAL" - means a Phase 2 clinical trial conducted
by FFF or its agents in which the safety and efficacy of the
Investigational Drug are evaluated in up to five (5) human patients
with primary immune deficiency for the purpose of obtaining approval
from the FDA of a Biologics License Application and a Treatment
Protocol.
1.22. "PHASE 3 CLINICAL TRIAL" - means a Phase 3 clinical trial conducted
by FFF or its agents in which the safety and efficacy of the
Investigational Drug are evaluated in up to fifty (50) human patients
with primary immune deficiency for the purpose of obtaining approval
from the FDA of a Biologics License Application and a Treatment
Protocol.
1.23. "REGULATORY FILINGS" - means any document required under the US
Federal Food, Drug and Cosmetics Act and associated regulations in
Title 21 of the CFR.
1.24. "SPONSOR" - means the same as in 21 CFR Section 312.3 and refers to
the entity that holds the IND for the investigational drug. The
Sponsor is responsible for compliance with all sponsor
responsibilities set forth in 21 CFR Part 312. FFF is the Sponsor of
the FFF IND, as defined in Section 1.10, above.
1.25. "TAXES" - means all taxes associated with the distribution, sale and
delivery of Omrigam NF, including but not limited to sales, use,
excise, withholding, value-added and similar taxes and all customs,
duties or other governmental impositions, but excluding taxes
calculated on Omrix's net income.
1.26. "TREATMENT PROTOCOL" - under this Agreement means a treatment
protocol ("TREATMENT PROTOCOL"), as described in 21 CFR Section
312.35(a), that will be submitted by FFF under the FFF IND to use the
Investigational Drug to treat US patients with primary immune
deficiency and other immune diseases who are not enrolled as subjects
in the Clinical Trials. The FDA may approve a Treatment Protocol as
early as during a Phase 2 clinical trial (21 CFR Section 312.34(a)).
Under a Treatment Protocol, the Investigational Drug may be
distributed to a specified group of physicians, who function as
Investigators, and who may provide the Investigational Drug to
patients in accordance with applicable informed consent (21 CFR Part
50) and Institutional Review Board (21 CFR Part 56) requirements. In
contrast to use in the Clinical Trials, the Parties may charge for the
use of the Investigational Drug under a Treatment Protocol under
conditions specified in 21 CFR Section 312.7(d)(2).
1.27. "TREATMENT PROTOCOL CHARGE PRICE" - means the price authorizedby the
FDA under 21 CFR Section 312.7(d)(2) to charge patients or their
insurance for the Investigational Drug provided to patients under the
Treatment Protocol.
1.28. "TREATMENT PROTOCOL PURCHASE PRICE" - means the price FFF shall pay
Omrix for the Investigational Drug that will be provided to patients
under the Treatment Protocol.
2. INVESTIGATIONAL DRUG
2.1. Omrigam NF. The Investigational Drug under this Agreement is Omrigam
NF, which may be used in the US only in the Clinical Trials and under
a Treatment Protocol, prior to approval by
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 3 of 27
the FDA of a Biologics License Application. Omrix is and remains under
this Agreement the exclusive owner of Omrigam NF.
2.2. Regulatory Status. The Investigational Drug is a biologic for which a
BLA has not yet been submitted to the FDA to obtain approval to market
the product in the US. FFF will be the sponsor of an amended IND for
the Investigational Drug (i.e., the FFF IND). The Parties' intent
under this Agreement is for FFF to use data collected in the Clinical
Trials to prepare a BLA that Omrix will submit to the FDA for approval
to market Omrigam NF in the US in the Commercial Phase, as defined in
section 1.5, above, and in accordance with section 3, below.
2.3. Quality Standards and Rejections.
a. Quality Standards. Omrix shall be responsible for supplying all
Investigational Drug used under this Agreement in compliance with
cGMP standards, the specifications in the Omrix IND for the
chemistry, manufacturing and quality control and all applicable
FDA requirements set forth in 21 CFR Part 312 for labeling,
packaging and shipping of investigational drugs (hereafter
collectively "MANUFACTURING SPECIFICATIONS").
b. Change in Manufacturing Specifications. Omrix will advise FFF in
writing of any proposed modifications to the Manufacturing
Specifications prior to implementation. Omrix will only implement
the modified Manufacturing Specifications after submitting to the
FDA (through FFF) an information amendment to supplement the IND,
if necessary under 21 CFR 312.23.
c. Rejections. FFF shall have the right to return to Omrix any
Investigational Drug FFF that upon receipt from Omrix does not
comply with Omrix's Manufacturing Specifications. FFF shall have
ten (10) calendar days ("Inspection Period") from receipt of a
shipment to perform a visual inspection for damage to the
packaging or immediate container and to reject any damaged
Investigational Drug in the shipment. FFF must send a written
rejection notice to Omrix within the ten (10) day Inspection
Period and must detail the basis for the rejection. FFF shall
return any damaged units of Investigational Drug to Omrix. Omrix
shall replace any rejected and returned damaged units of
Investigational Drug without cost to FFF providing that the
damage was not sustained after receipt of the Investigational
Drug by FFF. If FFF does not deliver written notice to Omrix
within the applicable Inspection Period of receipt of a shipment
that FFF rejects such shipment because of non-compliance, FFF
will be deemed to have accepted the shipment. If after an inquiry
by Omrix it will be determined that any rejection was made in
error, FFF will bear all costs associated with making such
determination and will immediately pay Omrix the above cost
together with any unpaid sum relating to the alleged
non-complying Investigational Drug, and any other cost incurred
by Omrix in connection with the alleged non-compliance.
2.4. Investigational Use. The Investigational Drug may be used under this
Agreement in the US only in the Clinical Trials and under a Treatment
Protocol, in compliance with all applicable FDA regulations and
approvals and in accordance with this Agreement.
2.5. Supply and Purchase Commitments.
a. Omrix shall supply all Investigational Drug necessary for timely
completion of the Clinical Trials and as needed to meet demand
under the Treatment Protocol, subject to the supply of recovered
plasma volume provided to Omrix under the DCI Contract.
b. Omrix agrees to sell to FFF and FFF shall purchase all
Investigational Drug produced by Omrix from recovered plasma
purchased pursuant to the DCI Contract provided, however, that
under no circumstances shall FFF be responsible for purchasing
more than *** of the Investigational Drug in any calendar year
unless Omrix has obtained prior written approval of FFF to
purchase such additional
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 4 of 27
amounts. Notwithstanding the foregoing, during any partial
calendar year under this Agreement, the number of grams of
Investigational Drug which FFF shall be required to purchase
shall be a pro rata amount based on the actual number of days
during such calendar year in which this Agreement is in force and
during which the Treatment Protocol is approved and effective.
c. Omrix shall assure that the Investigational Drug is shipped with
the statement, "Caution: New Drug - Limited by United States law
to investigational use," on the package label as required by 21
CFR Section 312.6.
2.6. Exclusive Distributor. FFF shall be the exclusive distributor of the
Investigational Drug in the US.
2.7. Handling Specifications. FFF shall be responsible for assuring that
the Investigational Drug is handled by FFF, Investigators, and FFF's
agents and subcontractors according to Omrix's specifications set
forth in the FFF IND for the handling, storage, use, transport and
general possession of Omrigam NF ("HANDLING SPECIFICATIONS"). FFF
shall be responsible for maintaining accurate and current records
regarding handling, storage and transport of the Investigational Drug
for review by Omrix and the FDA or other regulatory agencies.
2.8. Unused Investigational Drug. All unused quantities of Investigational
Drug that have been provided to FFF under this Agreement for use in
the Clinical Trials shall be destroyed by FFF, or, at Omrix's option,
returned to Omrix, at Omrix's cost, upon any of the following events:
i) the conclusion or termination of the Clinical Trials; ii) the IND
or Treatment Protocol is placed on clinical hold by the FDA under 21
CFR Section 312.34(d) and Section 312.42 for in excess of six (6)
months unless otherwise agreed by the Parties; iii) upon approval of a
BLA for Omrigam NF; or iv) upon termination of this Agreement. FFF
shall be responsible for assuring that Investigators return all unused
Investigational Drug to FFF for destruction or return to Omrix, as
applicable.
2.9. DCI Contract. The Parties recognize that Omrix has entered into a
5-year supply agreement with DCI (the "DCI Contract") that is
necessary for Omrix to provide Investigational Drug to FFF for use
under this Agreement. If this Agreement is terminated under Sections
15.2.b, 15.2.c, 15.3.a, 15.3.c or 15.3.d, then the Parties agree to
share equally any loss incurred or profit realized by Omrix under the
DCI Contract, provided, however, that FFF shall not be responsible for
any loss based on DCI providing Omrix with more than *** liters of
recovered plasma per calendar year unless Omrix has obtained FFF's
prior written agreement that FFF will bear responsibility for such
loss. If this Agreement is so terminated as set forth in the previous
sentence, Omrix will make commercially reasonable efforts to resell
such plasma and FFF agrees to be responsible to Omrix for an amount
equal to *** of the difference, if any, that the price Omrix pays for
such plasma is greater than the price that Omrix receives upon a
resale of such plasma *** and Omrix agrees to pay FFF an amount equal
to *** of the difference, if any, that the price Omrix pays for such
plasma is less than the price that Omrix receives upon a resale of
such plasma ***. Accordingly, FFF shall pay to Omrix fifty percent
(50%) of the amount due by Omrix under the DCI Contract at least five
(5) business days prior to the date that Omrix is due to pay such
amounts to DCI, and Omrix shall reimburse FFF such amount, less the
*** (or plus ***),if any, upon receipt of payment by a third party
for the plasma. For the purposes of this Section 2.9, the amount that
Omrix receives upon a resale shall be calculated net of all taxes,
shipping and other associated out of pocket expenses incurred by
Omrix in the resale of the plasma. Alternatively, if Omrix assigns
the DCI Contract, or agrees with DCI on a termination fee, or enters
into any other arrangement for disposal of the DCI Contract, then FFF
agrees to reimburse Omrix for *** of any cost or loss incurred by
Omrix resulting from entering into any such arrangement, provided
that such arrangement has been approved by FFF in advance and Omrix
agrees to pay FFF *** of any profit realized by Omrix resultin from
entering into any such arrangement. In addition, if this Agreement is
terminated by Omrix under Section 15.2.a or 15.2.d, or by FFF under
Section 15.3.e, FFF shall
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 5 of 27
be responsible for all amounts committed by Omrix in connection with
the DCI Contract; provided, however, that if Omrix requires FFF to
bear such costs in connection with such contract, FFF will have the
option to have the DCI Contract assigned to FFF, subject to the
approval of DCI, and Omrix shall have no obligations or liability
after such assignment. This Section 2.9 shall survive termination of
this Agreement. If Omrix enters into any other long term supply
agreements for recovered plasma during the Term, which are approved by
FFF in writing, then each party's responsibilities under such
agreements will be treated in the same manner as described in this
Section regarding the DCI Contract.
2.10. Payments to Fund Expansion. FFF shall pay to Omrix non-refundable
payments aggregating to ***, which Omrix will apply to expansion of
Omrix's capacity to manufacture Omrigam NF. Notwithstanding the
foregoing, Omrix will refund this amount to FFF only if the Agreement
is terminated under Section 15.2.b or 15.3.e (as regards the Treatment
Protocol Charge Price), to the extent such amount has not been
expended on such expansion. These payments will be made in six (6)
equal monthly installments of *** each. In the event the FDA approves
the use of the Investigational Drug in the Treatment Protocol for the
primary immune deficiency, ITP, CLL. BMT, pediatric HIV and Kawasaki's
Disease disease states, the first payment will commence ninety (90)
days after the Treatment Protocol is approved by the FDA. In the event
the FDA approves the use of the Investigational Drug in the Treatment
Protocol for the foregoing six (6) disease states and also for the
CIDP, GBS and Myasthenia Gravis neurological disorders, then the first
payment will instead commence thirty (30) days after the Treatment
Protocol is approved by the FDA.
3. COMMERCIAL PHASE
3.1. Post-FDA Approval. The Commercial Phase means the phase of the
relationship between the Parties after FDA approval of a Biologics
License Application has been obtained and Omrigam NF may be marketed
in the US.
3.2. Exclusive Distributor. The terms and conditions between the Parties
for the Commercial Phase are set forth in the agreement, SUPPLY AND
DISTRIBUTION AGREEMENT: COMMERCIAL PHASE ("COMMERCIAL PHASE
AGREEMENT"), attached hereto as Exhibit A. Under the Commercial Phase
Agreement, FFF shall be the exclusive distributor of Omrigam NF in the
US.
3.3. Commercial Phase Agreement. Execution of the Commercial Phase
Agreement is a concurrent condition of execution of this Agreement.
4. CLINICAL TRIALS
4.1. General Responsibilities.
a. FFF. FFF will be the sponsor of the Clinical Trials under the FFF
IND, as defined in section 1.10, above. FFF shall be responsible,
at its own cost, for conducting the Clinical Trials through a
qualified Contract Research Organization (CRO). FFF will be the
exclusive contact with the FDA on all matters related to the FFF
IND, the Clinical Trials and the Treatment Protocol. FFF shall
use its best reasonable efforts to conduct the Clinical Trials in
a timely manner and in accordance with this Agreement, the
approved protocol for the individual Clinical Trial and all
applicable federal, state and local regulatory requirements. FFF
shall keep Omrix informed in a timely manner of all regulatory
issues, the conduct of the Clinical Trials and use of the
Investigational Drug under the Treatment Protocol and will obtain
Omrix's approval prior to all regulatory decisions.
b. Omrix. Omrix shall use its best reasonable efforts to work
collaboratively and in a timely manner with FFF in meeting all
regulatory requirements related to the FFF IND, including
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 6 of 27
without limitation providing information requested by FFF for use
in correspondence with the FDA related to the Clinical Trials.
4.2. FFF Responsibilities.
a. Sponsor's Obligations. FFF shall be responsible for assuring that
all Sponsor obligations under 21 CFR Part 312 are met either by
FFF or as delegated by FFF to the CRO.
b. Contract Research Organization. FFF shall be responsible for
selecting and hiring a CRO to conduct the Clinical Trials, within
thirty (30) days of notice from the FDA of approval of the FFF
IND. FFF shall be responsible for overseeing and paying the CRO
to conduct the Clinical Trials.
c. Clinical Trials. FFF shall contract with the CRO to conduct the
following Clinical Trials:
1. Phase 2 Clinical Trial. Immediately upon hiring the CRO and
obtaining all necessary regulatory approvals from the FDA
and the IRB, the CRO shall initiate a Phase 2 Clinical Trial
with qualified Investigators in which the safety and
efficacy of the Investigational Drug will be evaluated in
five (5) or fewer patients with primary immune deficiency.
FFF and Omrix shall work closely with the CRO in preparing
detailed protocols for the Phase 2 Clinical Trial as needed
to obtain FDA clearance.
2. Phase 3 Clinical Trial. Upon conclusion of the Phase 2
Clinical Trial and obtaining all necessary regulatory
approvals from the FDA and the IRB, the CRO shall initiate a
Phase 3 Clinical Trial with qualified Investigators in which
the safety and efficacy of the Investigational Drug will be
evaluated in fifty (50) or fewer patients with primary
immune deficiency. FFF and Omrix shall work closely with the
CRO in preparing detailed protocols for the Phase 3 Clinical
Trial as needed to obtain FDA clearance.
d. Protection of Human Subjects. FFF shall be responsible for
assuring that the Clinical Trials are conducted in compliance
with all applicable FDA regulations protecting human subjects as
set forth in 21 CFR Parts 50 and 56. FFF shall assure that no
subject will receive the Investigational Drug until the
Investigator's IRB has obtained IRB approval of the Clinical
Trial protocol and informed consent form, the subject has been
fully informed of the risks and benefits of participating in the
Clinical Trial and the subject has signed the approved informed
consent form.
e. Regulatory Compliance. FFF shall be responsible for assuring that
the Clinical Trials are conducted in compliance with all
applicable FDA regulations, including without limitation the
following:
1. Compliance with Good Clinical Practices ("GCPS"), prudent
research practices and the IRB-approved protocol for the
individual Clinical Trial.
2. Compliance with the Health Insurance Portability and
Accountability Act of 1996, as codified at 42 USC Section
1320d ("HIPAA") and its implementing regulations, including
without limitation 45 CFR Parts 160 and 164 ("the Privacy
Regulations") and 45 CFR Parts 142 (the "Security
Regulations"), collectively the "HIPAA REQUIREMENTS." FFF
shall assure compliance with applicable HIPAA Requirements
for obtaining and disclosing protected health information
("PHI"), as that term is defined in 45 CFR Section 164.501,
in the Clinical Trials.
3. The CRO shall not retain, employ or involve any person in
conducting the Clinical Trials if such person is (i)
debarred by the FDA under 21 USC 335a; (ii) the subject of a
disqualification proceeding or is disqualified as a clinical
investigator pursuant to 21 CFR.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 7 of 27
Section 312.70; or (iii) has been excluded from
participation in any federal health care program pursuant to
Title XI of the Social Security Act.
4. FFF shall be responsible for obtaining from all
Investigators information regarding financial interests as
necessary for Omrix to comply with any disclosure
requirements to the FDA under 21 CFR Part 54.
f. Investigator's Brochure. FFF shall be responsible for assuring
that all Investigators receive a copy of the Investigator's
Brochure as required under 21 CFR Section 312.55(a).
g. Safety Information. FFF shall be responsible for assuring that
safety information regarding life-threatening, serious and/or
unexpected adverse drug experiences is collected during the
Clinical Trials as required under 21 CFR Section 312.32 and in
accordance with FDA guidance published November 30, 2005. FFF
shall promptly provide to Omrix written reports of any and all
such adverse drug experiences for Omrix's review and evaluation.
FFF shall notify Omrix immediately by telephone of any unexpected
or life-threatening adverse event associated with use of the
Investigational Drug. FFF shall be responsible for investigating
all safety information it receives and following-up as
appropriate under 21 CFR Section 312.32(d). FFF shall be
responsible for preparing and submitting written IND safety
reports as required under 21 CFR Section 312.32(c) on all serious
and unexpected adverse drug experiences to the FDA as soon as
possible but not later than fifteen (15) calendar days of
receiving notice of such experiences. FFF shall be responsible
for notifying the FDA of any unexpected fatal or life-threatening
drug experience by telephone or facsimile as soon as possible but
not later than seven (7) calendar days of receiving information
about such experiences.
h. Distribution and Disposition Investigational Drug. FFF shall be
responsible for assuring that the Investigational Drug is
distributed only to qualified Investigators for use in the
Clinical Trials in accordance with the approved protocol. FFF
shall assure that any and all unused quantities of the
Investigational Drug dispensed to Investigators for use in the
Clinical Trials are returned by Investigators to FFF and disposed
of by FFF in accordance with section 2.8, above. FFF shall
maintain complete, accurate and current records of the
disposition of all Investigational Drug as required under 21 CFR
Section 312.59 and provide such records to Omrix at the
conclusion of the Clinical Trials.
i. IND Information. FFF shall provide to Omrix the complete FFF IND
and copies of any amendments to the IND at least twenty-four (24)
hours prior to submission to the FDA.
j. Maintain FFF IND. FFF shall be responsible for complying with all
regulatory requirements necessary to maintain the FFF IND and
providing the FDA with any supplemental information to amend the
IND as required under 21 CFR Section 312.31.
k. Reports and Records. FFF shall be primarily responsible for
preparing all FDA required reports and records in consultation
with Omrix. FFF shall submit all required reports to the FDA. FFF
shall maintain all FDA required records for two (2) years after
approval of the BLA as required under 21 CFR Section 312.57(c) or
two (2) years after termination of this Agreement, whichever
occurs earlier.
4.3. Omrix Responsibilities.
a. Supply Investigational Drug. Omrix shall supply to FFF all
Investigational Drug necessary for the Clinical Trials at its
expense and free of charge, subject to volumes of recovered
plasma provided to Omrix under the DCI Contract. Omrix shall
provide the Investigational Drug in compliance with all
applicable FDA requirements for labeling, packaging and shipping
of investigational drugs set forth in 21 CFR Part 312. Such
packaging shall include all materials needed to infuse the
Investigational Drug or placebo.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 8 of 27
b. Maintenance of FFF IND. Omrix shall cooperate with FFF in
complying with all regulatory requirements necessary to maintain
the FFF IND as far as such requirements relate to the
manufacturing, labeling and shipping of the Investigational Drug
and providing FFF with any supplemental information needed to
amend the IND as required under 21 CFR Section 312.31.
c. Records. FFF and Omrix shall maintain adequate records of
shipments of Investigational Drug, as required under 21 CFR
Section 312.57(a) including the recipient, date, quantity, and
batch or code xxxx of each shipment.
d. Safety Information. Omrix shall review and evaluate all safety
information received from FFF and provide timely feedback to FFF
to allow FFF to comply with its safety reporting obligations as
described in section 4.2.g, above. Omrix shall cooperate with FFF
in investigating all serious adverse events associated with use
of the Investigational Drug, as required under 21 CFR Section
312.32(d).
e. Reports. Omrix shall cooperate with FFF as needed to prepare all
reports required by the FDA to assure timely submission of
complete and accurate reports.
4.4. Data. FFF shall own all data generated in the Clinical Trials. The
Parties shall consult with each other in the interpretation of the
data. FFF shall maintain the data as needed to prepare reports and
maintain records required under 21 CFR Part 312 and Omrix will use the
data to prepare the BLA. FFF shall provide Omrix with copies of all
data generated in the Clinical Trials on a regular basis, and, in any
case, no less frequently than quarterly. Upon termination of this
Agreement, Omrix shall cease to use all data provided to Omrix by FFF
pursuant to this section 4.4 unless FFF agrees otherwise in writing or
until the transfer of the data from FFF to Omrix in accordance with
section 15.4 of this Agreement.
5. TREATMENT PROTOCOL
5.1. FFF Responsibilities.
a. Treatment Protocol. FFF shall be responsible for obtaining a
Treatment Protocol, as defined in section 1.26, under the FFF IND
and in accordance with the provisions of this section 5.1.
1. Treatment Protocol. FFF shall prepare a treatment protocol
("Treatment Protocol") in consultation with and information
provided by Omrix and in accordance with 21 CFR Section
312.35(a) to use the Investigational Drug to treat patients
with primary immune deficiency who are not enrolled as
subjects in the Clinical Trials. FFF has been engaged in
discussions with the FDA regarding the Treatment Protocol
and shall continue to be responsible for negotiating the
terms of the Treatment Protocol with the FDA. FFF shall
prepare the Treatment Protocol in time for FFF to submit it
to the FDA immediately after initiation of the Phase 2
Clinical Trial with the goal of obtaining approval during or
immediately after the conclusion of the Phase 2 Clinical
Trial. FFF shall be the sponsor of the Treatment Protocol
and shall submit the Treatment Protocol to the FDA under the
FFF IND. In addition, FFF will provide Omrix with an
electronic copy of the packaging material which will be used
in the Treatment Protocol consistent with all FDA
requirements.
2. Approval of the Treatment Protocol. The Treatment Protocol
shall be deemed approved thirty (30) days after the date the
FDA receives the Treatment Protocol unless the FDA either:
(a) provides earlier notification that treatment use of the
Investigational Drug may begin or (b) places the Treatment
Protocol on clinical hold under 21 CFR Section 312.34(d). If
no communication has been received from the FDA within forty
(40) days of submission of the Treatment Protocol, Omrix and
FFF shall confirm with the FDA that treatment use of the
Investigational Drug may begin.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 9 of 27
b. Contract Research Organization. FFF shall be responsible for
selecting and hiring a CRO or equivalent within thirty (30) days
of approval of the Treatment Protocol, as defined in Section
5.1.a.2, above, to implement the Treatment Protocol, including
without limitation selecting qualified physicians as
Investigators, obtaining approval as needed by local IRBs,
assuring patients who receive the Investigational Drug have been
fully informed of the risks and benefits and have signed an IRB
approved informed consent form.
c. Distribution and Disposition of Investigational Drug. FFF shall
be the exclusive distributor of the Investigational Drug under
the Treatment Protocol. FFF shall assure that the Investigational
Drug is distributed in compliance with all applicable regulatory
requirements set forth in 21 CFR Section 312.34 and Section
312.35. FFF shall assure that any and all unused quantities of
the Investigational Drug dispensed under the Treatment Protocol
shall be returned by Investigators to FFF and disposed of by FFF
in accordance with section 2.8, above. FFF shall be responsible
for maintaining complete and accurate records of the disposition
of the Investigational Drug as required under 21 CFR Section
312.59.
d. Regulatory Compliance. FFF shall be responsible for assuring that
the Investigational Drug is distributed in compliance with all
applicable regulatory requirements generally related to INDs and
specifically those related to Treatment Studies set forth in 21
CFR Section 312.34 and Section 312.35, including without
limitation the following:
1. Investigators. Licensed practitioners who receive the
Investigational Drug under the Treatment Protocol are
Investigators under 21 CFR Section 312.35(a)(3).
Investigators who administer the Investigational Drug under
the Treatment Protocol shall be referred to hereafter as
"TREATMENT PROTOCOL INVESTIGATORS." FFF shall assure that
all Treatment Protocol Investigators comply with all
applicable requirements for "investigators" under 21 CFR
Part 312, sign FDA Form-1572 and provide information
regarding financial interests in compliance with 21 CFR Part
54.
2. Human Subject Protections. FFF shall be responsible for
assuring that the Investigational Drug is administered by
Investigators in compliance with all applicable requirements
for informed consent under 21 CFR Part 50 and IRBs under 21
CFR Part 56.
3. Safety Reports. FFF shall be responsible for assuring that
safety information is collected from Investigators
participating in the Treatment Protocol as required under 21
CFR 312.34 and shall promptly provide such information to
Omrix. FFF shall treat safety information collected under
the Treatment Protocol, as described in Section 4.2.g.,
above.
e. Monitor Effects. FFF shall be responsible for assuring that
information about the safety and effectiveness of the
Investigational Drug is collected from the Treatment Protocol
Investigators as required under 21 CFR Section 312.35(a)(1)(v).
f. Reports and Records. FFF shall be primarily responsible for
preparing reports of safety and effectiveness of the
Investigational Drug used under the Treatment Protocol and
providing such reports to Omrix in a timely manner. FFF shall
maintain all records for two (2) years after approval of the BLA
or two (2) years after termination of this Agreement, whichever
occurs earlier.
5.2. Omrix's Rights and Responsibilities.
a. Treatment Protocol. Omrix shall provide to FFF in a timely manner
any information in Omrix's possession about the Investigational
Drug that is necessary for FFF to prepare the Treatment Protocol,
including without limitation technical, pre-clinical, clinical,
and
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 10 of 27
information regarding the Manufacturing Specifications. Omrix
shall provide FFF with feedback in a timely manner on drafts of
the Treatment Protocol.
b. Investigational Drug. Omrix shall provide to FFF all
Investigational Drug needed for the Treatment Protocol in
accordance with sections 2, above and 5.4, below.
c. General Responsibilities. Omrix shall be responsible for meeting
the obligations of Omrix set forth in Sections 4.3. (b)-(e),
above as they relate to use of the Investigational Drug under the
Treatment Protocol
5.3. Data. FFF shall own all data regarding the effect of the
Investigational Drug provided under the Treatment Protocol. The
Parties shall consult with each other in the interpretation of the
data. FFF shall keep copies of all data as needed to prepare reports
and maintain records required under 21 CFR Part 312 and to prepare the
BLA. FFF shall provide Omrix with copies of all data regarding the
effect of the Investigational Drug under the Treatment Protocol on a
regular basis, and, in any case, no less frequently than quarterly.
Upon termination of this Agreement, Omrix shall cease to use all data
provided to Omrix by FFF pursuant to this section 5.3 unless FFF
agrees otherwise in writing or until the transfer of the data from FFF
to Omrix in accordance with section 15.4 of this Agreement.
5.4. Purchase of Investigational Drug.
a. Purchase Price of Investigational Drug. FFF shall purchase the
Investigational Drug from Omrix for distribution under the
Treatment Protocol at the price specified in the Treatment
Protocol Pricing Sheet, attached hereto as Exhibit C. This
purchase price shall be referred to hereafter in this Agreement
as the "TREATMENT PROTOCOL PURCHASE PRICE." The Treatment
Protocol Purchase Price shall be *** per gram, and shall be
subject to an upward price adjustment based on changes in the
cost of plasma under the DCI Contract The price adjustment will
be equal to *** of the change in the price under the DCI
Contract. For example, if the price per liter for recovered
plasma increases by *** per liter, then the corresponding
increase in the Treatment Protocol Purchase Price will be ***
per gram.
b. Charge Price of Investigational Drug.
1. FDA Price Limitations. The Parties acknowledge that under 21
CFR Section 312.7(d)(2) FFF may charge patients or their
insurance for use of the Investigational Drug used under the
Treatment Protocol. However, the FDA limits the price that
may be charged to reimbursement of costs related to the
manufacture, research, development and handling of the
Investigational Drug (21 CFR Section 312.7(d)(3)).
2. Treatment Protocol Charge Price. FFF and Omrix shall
collaboratively determine a price structure to charge
patients or their insurance for the Investigational Drug
provided under the Treatment Protocol that complies with 21
CFR Section 312.7(d)(3). This price shall be referred to
hereafter in this Agreement as the "TREATMENT PROTOCOL
CHARGE PRICE." The formulation of the Treatment Protocol
Charge Price is provided in the TREATMENT PROTOCOL PRICING
SHEET, attached hereto as Exhibit C. The Treatment Protocol
Charge Price shall consist of the Treatment Protocol
Purchase Price, as described above and a COST RECOVERY
AMOUNT. The Cost Recovery Amount that will be the sum of
itemized costs related to manufacturing the Investigational
Drug, conducting the Clinical Trials and distributing the
Investigational Drug under the Treatment Protocol. The
itemized costs and calculation of the Cost Recovery Amount
are set out in the Treatment Protocol Pricing Sheet. The
Treatment Protocol Charge Price must be authorized by FDA.
3. FDA Authorization of Charge Price. FFF shall prepare and
submit to the FDA a written notification of the proposed
Treatment Protocol Charge Price as required under 21 CFR
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 11 of 27
Section 312.(d)(2). The Treatment Protocol Charge Price is
deemed authorized by the FDA and may be put into effect
thirty (30) days after the FDA receives the notification,
unless the FDA notifies FFF to the contrary. FFF shall keep
Omrix informed in a timely manner of all communications with
the FDA regarding authorization of the Treatment Protocol
Charge Price.
c. Purchase by FFF of Investigational Drug.
1. Promotion and Advertising. The Parties acknowledge that FDA
regulations prohibit commercial promotion or advertising of
the Investigational Drug used under the Treatment Protocol
(21 CFR Section 312.7(d)(2)). Any informational material
used in connection with the Treatment Protocol must be
approved by Omrix.
2. Orders. FFF shall submit quarterly written purchase orders
to Omrix for the Investigational Drug to be used under the
Treatment Protocol. The amount of FFF's purchase orders
shall be based on the quantity of Investigational Drug
manufactured by Omrix using recovered plasma obtained under
the DCI Contract but shall be subject to the limitations set
forth in section 2.5, above. All signed purchase orders must
be faxed to Omrix at x000-0-000-0000. Purchase orders shall
be signed by an authorized official of FFF and shall
specify: (a) the purchase order number; (b) quantities; (c)
Treatment Protocol Purchase Price; (d) requested delivery
schedule; (e) preferred shipping method; (f) exact "Ship to"
address; and (g) any other relevant detail. All purchase
orders shall be binding on the Parties only after FFF has
received written confirmation of the order from Omrix. Omrix
reserves the right to cancel, suspend, refuse, or delay any
orders if FFF fails to make payment when due as required in
Section 5.4.c.4, below or otherwise fails to comply with the
terms and conditions of this Agreement.
3. Forecasts; Delivery. During the Term of this Agreement,
Omrix shall, by November 30th of each calendar year, provide
FFF with a non-binding good faith forecast for the following
calendar year, broken down into months, for the quantity of
the Investigational Drug that Omrix anticipates producing
under the DCI Contract. The forecast will be updated every
other month, or more frequently, as determined by Omrix. The
Parties acknowledge that the actual supply of the
Investigational Drug that Omrix is obligated to provide is
subject to volumes provided under the DCI Contract. Omrix
shall ship the quantity of Investigational Drug ordered, in
accordance with the shipping dates set forth in the
forecasts. Omrix shall be responsible for payment of the
costs of shipping and insurance associated with the delivery
the Investigational Drug. Delivery will be FOB at FFF's
designated facility in the United States or at any
alternative receiving location if agreed in writing by the
Parties. Risk of loss in the Investigational Drug shall pass
to FFF at the time the Investigational Drug is received by
FFF.
4. Invoices. Omrix shall invoice FFF upon shipment (i.e., when
shipped from Omrix's plant) for the Treatment Protocol
Purchase Price for all shipped Investigational Drug. The
terms for all invoices shall be net 60 calendar days from
the invoice date, unless paid within 30 calendar days, which
30-day payments will receive a 2% discount. If FFF disagrees
for any reason with the amount of an invoice submitted by
Omrix, FFF shall notify Omrix in writing of such
disagreement within fifteen (15) calendar days of receipt of
such invoice and the Parties shall promptly attempt to
resolve the difference.
5. Payments. FFF shall pay Omrix the Treatment Protocol
Purchase Price in US dollars for all received
Investigational Drug that is not rejected by FFF under
section 2.3.c, above. Payments not received by Omrix when
due are subject to a late payment charge at the lower of:
(i) one and one half percent (1.5%) per month; (ii) the
maximum interest permitted under applicable law. Payments
are exclusive of all shipping and distribution costs and
Taxes, which shall be borne by FFF. FFF shall pay all Taxes
associated with the sale and delivery of all Investigational
Drug. All payments to Omrix hereunder
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 12 of 27
represent net amounts to be received by Omrix. If any Taxes
are found to be applicable to such payments to Omrix and/or
if FFF shall be required to deduct, collect, withhold or pay
such Taxes, the sum payable to Omrix shall be increased as
may be necessary so that after making all required
deductions, Omrix receives the amount equal to the sum it
would have received had no such deductions been made.
6. BIOLOGICS LICENSE APPLICATION
6.1. FFF Responsibilities.
a. Preparation of BLA. FFF shall be primarily responsible for
preparing a clinical study report for the BLA demonstrating the
safety, purity and potency of Omrigam NF in patients with primary
immune deficiency, in accordance with 21 CFR Section 601.2
(hereafter, the "OMRIGAM NF BLA"). FFF shall consult extensively
with Omrix in preparing drafts for review and comment by Omrix
and shall obtain from Omrix written approval of a final report
for Omrix to submit to the FDA. FFF shall aim to complete the
clinical study report as soon as sufficient data are available
from the Clinical Trials and the Treatment Protocol to meet FDA
requirements.
b. Costs. FFF shall be responsible for paying all fees and costs
associated with preparing and submitting the Omrigam NF BLA to
the FDA.
6.2. Omrix Rights and Responsibilities.
a. Information. Omrix shall provide to FFF in a timely manner all
relevant and material information in Omrix's possession needed by
FFF to prepare the Omrigam NF BLA in accordance with 21 CFR
Section 601.2, including without limitation: data from
pre-clinical and clinical studies and statements of compliance
with 21 CFR Parts 50, 54 and 56 for all clinical studies.
b. Regulatory Compliance.
1. Omrix shall be responsible for assuring that its
manufacturing establishments meet applicable requirements to
ensure the safety, purity and potency of Omrigam NF,
including compliance with all applicable cGMP requirements.
2. Omrix shall make its establishments and records available to
the FDA and its agents for inspections related to the FDA's
consideration and approval of the Omrigam NF BLA. Omrix
shall also make samples of Omrigam NF available as requested
by the FDA for inspection and assessment.
3. Omrix shall assure compliance with any required
environmental assessment under 21 CFR Part 25.
6.3. Omrix shall submit the Omrigam NF BLA to the FDA and be responsible
for all related communication and correspondence with the FDA. Omrix
shall promptly inform FFF of all communications with the FDA related
to the Omrigam NF BLA and provide FFF with copies of all written
correspondence with the FDA regarding same.
6.4. Omrix shall be the exclusive owner of the Omrigam NF BLA and, if
approved by the FDA, Omrix shall be the exclusive owner of the
biologics license for Omrigam NF (hereafter, the "OMRIGAM NF BIOLOGICS
LICENSE").
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 13 of 27
7. REGULATORY FILINGS
7.1. FFF shall be primarily responsible for preparing and paying all fees
and costs associated with all Regulatory Filings. Omrix shall provide
FFF with timely assistance and all information necessary to prepare
Regulatory Filings as required.
7.2. All correspondence and contact with the FDA related to Regulatory
Filings and work performed under this Agreement shall be through FFF
with the exception of the BLA as described in section 6.3 above.
7.3. Except for data specified under sections 4.4 and 5.3, Omrix shall be
the exclusive owner of all Regulatory Filings with the exception of
the BLA and Omrigam NF BL, which shall be owned exclusively by Omrix.
8. RECORDS
8.1. Recordkeeping.
a. FFF shall keep complete, accurate and current records and
accounts of work performed under this Agreement.
b. Omrix shall keep complete, accurate and current records and
accounts related to performance of its responsibilities under
this Agreement.
8.2. Maintenance of Records. The Parties shall maintain all records and
accounts related to work performed under this Agreement and all
Regulatory Filings for at least least two (2) years following
termination of this Agreement. Thereafter, the parties shall notify
each other at least sixty (60) days before destroying or discarding
any records. The party receiving such notice may request that the
other party send it such records, at the requesting party's expense,
upon written notice.
9. INSPECTIONS AND RECALLS
9.1. Inspections by Omrix.
a. FFF shall permit Omrix, at Omrix's expense, to examine FFF's
records, books, ledgers and records related to work performed
under this Agreement during regular business hours and with five
(5) business-day prior written notice. Omrix shall bear the
expense of such inspections, which shall not exceed one per year.
b. FFF shall assure that Omrix shall be permitted during the term of
this Agreement to conduct monitoring visits of facilities at
which Clinical Trials are conducted and at which the
Investigational Drug is distributed under the Treatment Protocol.
Such monitoring visits shall be conducted at reasonable times
during normal business hours with reasonable prior written notice
and shall include inspection of case report forms and related raw
and clinical data, source documents, informed consent forms and
other documents for the purpose of confirming compliance with
regulatory requirements and accuracy of data.
9.2. Inspection by FFF. Omrix shall permit FFF representatives to inspect
Omrix's facility and manufacturing processes and to test samples at
reasonable times during normal business hours with reasonable prior
written notice for the purpose of confirming compliance with the
Manufacturing Specifications.
9.3. Recalls and Withdrawals. At Omrix's request, FFF will recall all
Investigational Drug distributed by FFF, as soon as practically
possible. In the event of any recall or withdrawal of the
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 14 of 27
Investigational Drug, whether voluntary (as determined by Omrix in its
sole discretion) or involuntary, FFF shall be responsible for all
costs in connection therewith if related to the storage or shipment of
the Investigational Drug and Omrix shall be responsible for all costs
in connection therewith in all other situations. In any case,
following notification of a recall, the Parties will cooperate to
carry out any required recall.
10. CONFIDENTIALITY
10.1. Confidential Information. The Parties agree to protect the
confidentiality of all "CONFIDENTIAL INFORMATION." For purposes of
this Agreement, Confidential Information shall include all data and
information generated or derived as the result of the work performed
under this Agreement, the terms and existence of this Agreement, all
Regulatory Filings, Omrix Technology, as defined in Section 1.20,
above, and any and all materials or information in written, oral, or
any other form concerning processes, methods, apparatus,
specifications, products, materials, inventions, literature, patents
(including applications and rights in either), finances, personnel,
including any matters not technically or legally considered trade
secrets, and any other information related to the business or
activities of any disclosing Party which is not generally known to
third parties. Confidential Information shall be designated
"Confidential" when disclosed, provided that, if Confidential
Information is not marked "Confidential" but, under the circumstances
surrounding the disclosure, such information should in good faith to
be treated as Confidential Information, the receiving Party shall
treat such information as Confidential Information. Confidential
Information does not include information that:
a. Has been in the public domain prior to such disclosure;
b. Becomes part of the public domain through no breach of an
obligation by the receiving Party or its employees;
c. Is furnished to the receiving Party by others or by a third party
who was or is not under an obligation of confidence to the
disclosing Party at the time of the disclosure to the receiving
Party;
d. Is or can be accurately documented to have been independently
developed by the receiving Party, provided that information was
not acquired directly or indirectly from the disclosing Party;
however, the burden of proving that information disclosed by one
Party to the other should not be considered "Confidential
Information" shall be the receiving Party's; or
e. Is required to be disclosed pursuant to court order, legal
proceeding or as required by law or regulation and the receiving
Party first notifies the disclosing Party of the required
disclosure.
10.2. Confidentiality Obligations. The Parties agree to not disclose,
resell, transfer or use Confidential Information for any purpose other
than performance of work under this Agreement, without the prior
written consent of the disclosing Party. This provision shall remain
in effect throughout the term of this Agreement and for a period five
(5) years following the termination of this Agreement. The disclosing
Party's Confidential Information provided to the receiving Party shall
remain the exclusive property of the disclosing Party and shall be
returned promptly to the disclosing Party upon written request or upon
termination or expiration of this Agreement. Upon mutual agreement of
the Parties, in lieu of returning Confidential Information, a
receiving Party may destroy Confidential Information and provide
written certification to the disclosing Party that such destruction
took place.
10.3. Permitted Disclosures. Notwithstanding the sections 10.1 and 10.2,
above, (i) the Parties may, to the extent necessary, disclose and use
Confidential Information to prepare Regulatory Filings, to obtain a
Treatment Protocol and approval of a BLA for Investigational Drug, to
fulfill all regulatory requirements related to work performed under
this Agreement including, without
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 15 of 27
limitation, correspondence with the FDA, the IRB and officials
responsible for research compliance at the Clinical Trial and
Treatment Protocol facilities, and to comply with securities and other
agency regulations upon advice of counsel and (ii) the Parties may, to
the extent necessary, disclose Confidential Information to their
affiliates, attorneys, and accountants, or to any potential investor
or acquirer of a substantial part of such Party's business (whether by
merger, sale of assets, sale of stock, or otherwise) that is bound by
a written agreement to keep such terms confidential, or as may be
required by law.
11. INTELLECTUAL PROPERTY
11.1. Omrix Intellectual Property. All right, title and interest in and to
all Omrix Intellectual Property, as defined below, shall be the sole
and exclusive property of Omrix. Nothing in this Agreement should be
construed to confer upon or grant to FFF any right, title and interest
therein.
a. Under this Agreement, "OMRIX INTELLECTUAL PROPERTY" includes the
following: Omrix Technology, as that term is defined in section
1.20; patents, patent applications, patent disclosures and all
related continuation, continuation-in-part, divisional, reissue,
reexamination, utility model, certificate of invention and design
patents, patent applications, registrations and applications for
registrations; trademarks, service marks, trade dress, Internet
domain names, logos, trade names and corporate names and
registrations and applications for registration thereof;
copyrights and registrations and applications for registration
thereof; mask works and registrations and applications for
registration thereof; computer software, data and documentation;
inventions, trade secrets and confidential business information,
whether patentable or nonpatentable and whether or not reduced to
practice, know-how, manufacturing and product processes and
techniques, research and development information, copyrightable
works, financial, marketing and business data, pricing and cost
information, business and marketing plans and customer and
supplier lists and information; and copies and tangible
embodiments thereof.
b. During the Term of this Agreement, Omrix grants to FFF the right
and license to use and display Omrix Marks in a manner to be
approved in advance by Omrix for the exclusive purpose of
performing the work described in this Agreement. Any such use
shall inure to the benefit of Omrix and shall be in accordance
with Omrix's guidelines or other instructions regarding the use
of the Omrix Marks, which Omrix may modify from time to time at
its sole discretion. FFF will not make or permit alteration of
the Omrix Marks or removal or modification of any notices or
other identifying marks placed by Omrix or its agents on Omrigam
NF or associated literature. The right granted hereunder is only
in connection with the use of Omrigam NF as the Investigational
Drug in the Clinical Trials and under a Treatment Protocol.
c. FFF expressly agrees that the name "Omrix," "Omrigam NF" and any
related designs are the sole property of Omrix. It is further
understood that there may be in the future other commercial names
or marks identified with Omrix's products, and that the same are
the property of Omrix. The said names, designs, and other marks
are referred to collectively herein as the "OMRIX MARKS" which
marks Omrix may, in its sole discretion, revise from time to
time. FFF hereby acknowledges and agrees that Omrix shall retain
ownership of all intellectual property rights in the Omrix Marks,
including, but not limited to, any and all, modifications and
derivatives thereto. All rights not expressly granted to FFF
herein are reserved by Omrix.
d. Upon termination or expiration of this Agreement, FFF shall
return to Omrix all Omrix Intellectual Property, provided that
FFF may retain one copy of any documentation if necessary to
comply with regulatory requirements, and that FFF may, in lieu of
returning Omrix's Intellectual Property, request permission from
Omrix to destroy such property and provide written certification
to Omrix of such destruction.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 16 of 27
11.2. FFF Intellectual Property. All right, title and interest in and to
all FFF Intellectual Property, as defined below, shall be the sole and
exclusive property of FFF. Nothing in this Agreement should be
construed to confer upon or grant to Omrix any right, title and
interest therein.
a. Under this Agreement, "FFF INTELLECTUAL PROPERTY" includes:
trademarks, service marks, trade dress, Internet domain names,
logos, trade names and corporate names and registrations and
applications for registration thereof; copyrights and
registrations and applications for registration thereof; mask
works and registrations and applications for registration
thereof; computer software, data and documentation; inventions,
trade secrets and confidential business information, whether
patentable or nonpatentable and whether or not reduced to
practice, know-how, manufacturing and product processes and
techniques, research and development information, copyrightable
works, financial, marketing and business data, pricing and cost
information, business and marketing plans and customer and
supplier lists and information; and copies and tangible
embodiments thereof.
b. Upon termination or expiration of this Agreement, Omrix shall
return to FFF all FFF Intellectual Property, provided that Omrix
may retain one copy of any documentation if necessary to comply
with regulatory requirements, and that Omrix may, in lieu of
returning FFF's Intellectual Property, request permission from
FFF to destroy such property and provide written certification to
FFF of such destruction
12. PUBLICITY
During the term of this Agreement, neither Party shall, without the prior
written consent of the other Party, use the other Party's name, trademark,
logo, symbol or other image in connection with any products, promotion or
advertising, nor disclose the existence or substance of this Agreement
except as required by law or permitted under Section 10.
13. INDEMNIFICATION
13.1. Omrix shall indemnify, defend and hold harmless FFF and its
affiliates and their directors, officers, employees and agents and
subcontractors from and against any and all losses, damages,
liabilities, reasonable attorney fees, court costs, and expenses,
joint or several, as finally determined by court, regulatory agency,
arbitration or under settlement from third party claims arising out
of, resulting from, or in any manner caused (i) by breach of this
Agreement by Omrix or (ii) by Omrix's wilful misconduct or negligence,
or (iii) by the Investigational Drug due to its condition prior to or
upon delivery to FFF, or (iv) by infringement of any third party's
intellectual property relating to the manufacturing, importing, use or
sale of the Investigational Drug. If the Investigational Drug is, or
in Omrix's opinion, might be held to infringe as set forth above,
Omrix may, at its option and cost, replace or modify the
Investigational Drug so as to avoid infringement, or procure the right
for FFF to continue the use and sell the Investigational Drug. The
indemnification set forth in this section 13.1 shall be FFF's sole
remedy and Omrix's sole liability arising out of Claims of
infringement.
13.2. FFF shall indemnify, defend and hold harmless Omrix and its
affiliates, and their directors, officers, employees and agents and
subcontractors from and against any and all losses, damages,
liabilities, reasonable attorney fees, court costs, and expenses,
joint or several, as finally determined by court, regulatory agency,
arbitration or under settlement from third party claims arising out
of, resulting from, or in any manner caused (i) by breach of this
Agreement by FFF or (ii) by FFF's wilful misconduct or negligence, or
(iii) by the Investigational Drug due to any modification or
adulteration of the Investigational Drug occurring after delivery to
FFF while under FFF's control and possession and prior to delivery to
an Investigator or treating physician.
13.3. In the event that either Party seeks indemnification (the
"INDEMNIFIED PARTY") under the terms of this section, the Indemnified
Party shall notify the other Party (the "INDEMNIFYING PARTY"), in
writing, of the action, suit, proceeding, claim, liability, demand or
assessment giving rise to the
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 17 of 27
claim for indemnification as soon as reasonably practicable after its
assertion. The Indemnified Party shall permit the Indemnifying Party,
at the Indemnifying Party's cost, to assume direction and control of
the defense of the claim, and shall cooperate as requested (at the
expense of the Indemnifying Party), in the defense of the claim. The
Indemnified Party shall not settle or otherwise compromise any claims
or suit without the prior written consent of the Indemnifying Party.
14. INSURANCE
14.1. Insurance.
a. FFF. FFF shall procure and maintain, at its own expense, in full
force and effect at all times during this Agreement insurance
coverage written by a responsible insurance carrier, Best Rated
A, including general liability, including products liability
insurance with limits of not less than $10 million ($10,000,000)
per occurrence and $10 million ($10,000,000) in the aggregate.
b. Omrix. Omrix shall procure and maintain, at its own expense, in
full force and effect at all times during this Agreement
insurance coverage written by a responsible insurance carrier,
Best Rated A, including general liability insurance, including
product liability, with limits of not less than $10 million
($10,000,000) per occurrence and $10 million ($10,000,000) in the
aggregate.
c. Clinical Trial Insurance. FFF shall procure and maintain, in full
force and effect at all times during this Agreement clinical
trial insurance coverage written by a responsible insurance
carrier, Best Rated A, with limits of $10 million ($10,000,000)
per occurrence and $10 million ($10,000,000) in the aggregate.
The cost of such insurance will be shared equally by the Parties.
d. General Requirements. Each Party's insurance policy referred to
above shall name both Parties hereto as additional insureds and
will provide for at least thirty (30) days prior written notice
to the other Party of the cancellation or substantial adverse
modification thereof. Each Party shall deliver a certificate of
such insurance to the other Party promptly upon issuance of the
policy and shall, from time to time as reasonably requested by
such other Party, furnish such other Party with evidence of the
maintenance thereof. If any of the insurance policies described
herein are written on a claims made basis, the applicable party
maintaining such insurance agrees either to (a) continue to
purchase such coverage or (b) purchase an extended reporting
period endorsement ("tail" insurance), in either instance for the
entire term as defined in section 15.1, below ("TERM") of this
Agreement, and for a period of two (2) years after the end of
such Term to cover claims that might arise from the Clinical
Trials or patients who receive the Investigational Drug under the
Treatment Protocol.
14.2. Subject Injuries. Omrix shall be responsible for the cost of
reasonable and necessary medical care required by any subject or
patient who receives the Investigational Drug under this Agreement for
any injury that is the immediate and direct result of use of the
Investigational Drug ("SUBJECT INJURIES"), excluding costs that arise
directly from: a) an Investigator's failure to adhere to the terms of
the Clinical Trial or the Treatment Protocol; or b) negligence or
willful misconduct on the part of FFF, the CRO or the Investigator.
FFF shall be responsible for the cost of reasonable and necessary
medical care for all other Subject Injuries for which Omrix is not
responsible under this section 14.2.
15. TERM AND TERMINATION
15.1. Term. The Term of this Agreement shall begin on the Effective Date
and shall remain in effect until approval of the Omrigam NF BLA unless
terminated sooner as provided this section 15.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 18 of 27
15.2. Termination by Either Party. Either Party may terminate this
Agreement by giving the other Party written notice if any of the
following occurs:
a. If a Party materially breaches, or materially fails to perform,
its obligations under this Agreement and fails to cure such
breach or nonperformance within thirty (30) days after receiving
written notice thereof, the non-breaching Party in its sole
discretion may terminate this Agreement upon prior notice to the
defaulting Party;
b. If the Treatment Protocol is not approved within TWO (2) MONTHS
from when the Treatment Protocol was received by the FDA; or if
the Treatment Protocol is approved by the FDA and (i) approval is
subsequently revoked or (ii) the Treatment Protocol is placed on
clinical hold and the Treatment Protocol cannot be reinstated
without undue hardship to either Party;
c. The FDA withdraws the FFF IND or places the FFF IND on clinical
hold and the IND cannot be reinstated without undue hardship to
either Party; or
d. The other Party is declared insolvent or bankrupt by a court of
competent jurisdiction, or a voluntary petition of bankruptcy is
filed in any court of competent jurisdiction by the other Party,
or the other Party makes or executes any assignment for the
benefit of creditors, or a receiver is appointed to control the
business of the other Party.
15.3. Termination by FFF. FFF may terminate this Agreement by giving Omrix
written notice if any of the following occurs:
a. FFF's out-of-pocket expenses for conducting the Clinical Trials
exceeds *** (unless Omrix is willing to bear the excess cost);
b. Omrix fails to supply the Investigational Drug in accordance with
sections 2, 4.3 and 5.2 of this Agreement and Omrix fails to
remedy such failure within three (3) months of receiving a
written request from FFF to remedy such failure;
c. Approval of the BLA appears unlikely due to the occurrence of a
serious or life-threatening adverse event, as defined in 21 CFR
Section 312.32, that is related to the Investigational Drug as
shipped by Omrix or Omrix has not submitted the BLA within one
hundred twenty (120) days from the date that FFF has provided
Omrix with all data under FFF's responsibility necessary for the
BLA, including all clinical data and the final clinical study
report;
d. On or after September 1, 2007, (i) the BLA has not been approved
due to the fact that the Clinical Trials have not demonstrated
the effectiveness of the Investigational Drug or (ii) the BLA has
not been approved due to adverse regulatory action against Omrix
or the facility at which the Investigational Drug is manufactured
or (iii) Omrix has not completed the facility expansion to enable
the production of *** grams of the Investigational Drug per year;
e. If the Treatment Protocol Charge Price is less than *** per gram
or after FDA approval of the Treatment Protocol but prior to
approval of the BLA, subject to payment by FFF to Omrix of (a)
all then outstanding orders issued to Omrix hereunder, plus (b)
up to a maximum amount of *** for the Investigational Drug
supplied by Omrix for the Clinical Trials at the Treatment
Protocol Purchase Price, plus fulfillment of the responsibilities
set forth in Section 2.9.
15.4. Effect of Termination. Upon expiration in accordance with section
15.1, above, or receipt by either Party of written notice of
termination of this Agreement in accordance with sections 15.2 or
15.3, (a) the Clinical Trials shall be closed to enrollment and no
additional Investigational Drug shall be dispensed to enrolled
subjects or to patients under the Treatment Protocol; and (b) each
Party shall within thirty (30) days return or destroy all Confidential
Information in accordance with section 10, above, and Intellectual
Property in accordance with Section 11, above. Notwithstanding the
foregoing, upon termination of this Agreement, upon request by
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 19 of 27
Omrix, FFF shall assist Omrix as necessary to transfer to Omrix the
sponsorship of FFF IND, and all associated contracts (e.g., the CRO
agreement), and shall provide to Omrix all data and information
associated with the Clinical Trials and the Treatment Protocol. Upon a
termination of this Agreement, FFF agrees to transfer ownership of all
such data and information to Omrix, provided that if FFF terminates
this Agreement due to the breach of Omrix under Section 15.2.a, then
the ownership of such data will only be transferred to Omrix upon
payment by Omrix of FFF's out-of-pocket expenses incurred conducting
the Clinical Trials.
16. INDEPENDENT CONTRACTORS.
The relationship between the Parties established by this Agreement is that
of independent contractors, and nothing herein shall be construed to
constitute the Parties as partners, joint venturers, co-owners or otherwise
as participants in a joint or common undertaking. Neither Party shall have
any authority to obligate the other in any respect nor hold itself out as
having any such authority.
17. LIMITED WARRANTY; LIMITATION OF LIABILITY.
17.1. Limited Warranty. Omrix warrants that all Investigational Drug will
materially meet the Manufacturing Specifications, as defined in
Section 1.17, above, at the time that the Investigational Drug is
delivered to FFF. EXCEPT AS EXPRESSLY SET FORTH IN THE PRECEDING
SENTENCE, THE INVESTIGATIONAL DRUG IS PROVIDED "AS IS", AND NO OTHER
WARRANTIES, EITHER EXPRESSED OR IMPLIED, ARE MADE WITH RESPECT TO THE
INVESTIGATIONAL DRUG, INCLUDING, WITHOUT LIMITATION THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
FFF'S SOLE AND EXCLUSIVE REMEDY FOR ANY BREACH OF THE FOREGOING
LIMITED WARRANTY WILL BE, AT OMRIX'S OPTION, REPLACEMENT OF THE
INVESTIGATIONAL DRUG OR REFUND THE AMOUNT PAID, IF ANY.
17.2. EXCLUSION OF DAMAGES. EACH PARTY SHALL NOT UNDER ANY CIRCUMSTANCES BE
LIABLE TO THE OTHER OR ANY THIRD PARTY FOR ANY SPECIAL, INCIDENTAL,
INDIRECT, PUNITIVE OR CONSEQUENTIAL DAMAGES ARISING IN ANY WAY UNDER
THIS AGREEMENT OR FROM DEFECTS IN OR USE OF THE INVESTIGATIONAL DRUG
UNDER ANY THEORY OF LIABILITY, EVEN IF A PARTY IS INFORMED IN ADVANCE
OF THE POSSIBILITY OF SUCH DAMAGES; PROVIDED THAT THE FOREGOING SHALL
NOT APPLY TO DAMAGES AWARDED IN THE CASE OF PERSONAL INJURY OR DEATH
OR FOR BREACH OF CONFIDENTIALITY.
17.3. LIABILITY CAP. TO THE EXTENT PERMISSIBLE UNDER APPLICABLE LAW, IN NO
EVENT WILL EITHER PARTY'S LIABILITY IN CONNECTION WITH THE
INVESTIGATIONAL DRUG OR THIS AGREEMENT EXCEED $10,000,000. THESE
LIMITATIONS APPLY TO ALL CAUSES OF ACTION IN THE AGGREGATE. THIS
LIMITATION SHALL NOT APPLY TO AMOUNTS OWING FOR REQUIRED PURCHASES OF
THE INVESTIGATIONAL DRUG BY FFF UNDER THIS AGREEMENT, INCLUDING AS
REQUIRED UNDER THE DCI CONTRACT. THE FOREGOING LIMITATIONS IN THIS
SECTION 17.3 SHALL NOT APPLY TO DAMAGES AWARDED IN THE CASE OF
PERSONAL INJURY OR DEATH OR INFRINGEMENT UNDER SECTION 13.
18. ASSIGNMENT AND DELEGATION
This Agreement may not be assigned by either Party without the prior
written consent of the other Party, except that either Party shall be
permitted to assign this Agreement, without the other Party's consent, to
an affiliate or a company acquiring all or substantially all of the first
Party's relevant assets, voting stock or business to which this Agreement
relates, upon written notice to the other Party.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 20 of 27
Such assignment shall be subject to the assignee agreeing in writing to
assume the benefits and obligations of this Agreement. Any assignment made
without prior written consent, if such consent is required, shall be wholly
void and invalid. If a party is reorganized in such a manner that a
substantial portion of the assets of the party are transferred to an
Affiliate, then such party shall require such Affiliate to guaranty the
performance of such party's obligations under this Agreement. Anything to
the contrary herein notwithstanding, each Party agrees that the right and
obligations under this Agreement of the other Party may, from time to time,
be exercised or performed, as the case may be, in whole or in part by
Affiliates of such Party; provided that each Party shall remain liable for
any such obligations delegated to its Affiliates. As used in this section
18, "Affiliate" means any entity controlled by, controlling, or under
common control with a party to this Agreement, through ownership or control
of more than 50% of the voting power of the shares or other means of
ownership or control, provided that such control continues to exist.
19. GOVERNING LAW AND VENUE
This Agreement shall be governed by and construed and enforced in
accordance with the laws of the State of New York without regard to
conflict of laws principles. Any action or proceeding arising out of this
Agreement permitted to be brought in court under section 20.2 will be
litigated in courts located in New York. Each Party consents and submits to
the jurisdiction of any local, state, or federal court located in New York
for this purpose.
20. DISPUTE RESOLUTION
20.1. Initial Efforts. The Parties agree to use their best efforts to
resolve any controversy or claim arising out of or relating to this
Agreement through good faith negotiations for a thirty (30) day
period, unless otherwise agreed by the parties.
20.2. Arbitration. The Parties agree that any dispute, controversy or claim
that is not resolved under section 20.1, above, shall be settled by
binding arbitration under the then current Commercial Arbitration
Rules of the American Arbitration Association. Any such arbitration
shall be conducted in New York City, in the English language. The
arbitration shall be conducted by a sole arbitrator who shall be
appointed by mutual agreement of the Parties. The Arbitrator shall be
appointed by agreement of the Parties; provided, if the Parties fail
to agree upon the Arbitrator within thirty (30) days of notice of
arbitration provided by either Party, the Arbitrator shall be
appointed by the American Arbitration Association. Upon rendering an
award or a decision, the Arbitrator shall set forth in writing the
basis of such award or decision. The Arbitrator's awards and decisions
shall be final and binding upon the Parties. Judgment on the award or
any other final or interim decision rendered by the Arbitrator may be
entered, registered or filed for enforcement purposes in any court
having jurisdiction thereof. The Parties agree that, any provision of
applicable law notwithstanding, they will not request, and the
arbitrator shall have no authority to award, punitive or exemplary
damages against any Party. The costs of any arbitration, including
administrative fees and fees of the arbitrator(s), shall be shared
equally by the Parties, unless otherwise specified by the arbitrator.
Each Party shall bear the cost of its own attorneys' and expert fees;
provided that the arbitrator(s) may in their discretion award to the
prevailing Party the costs and expense incurred by the prevailing
Party in connection with the arbitration proceeding.
20.3. Attorney Fees. If any arbitration or litigation is instituted to
interpret, enforce, or rescind this Agreement, including but not
limited to any proceeding brought under the US Bankruptcy Code, the
prevailing Party on a claim will be entitled to recover with respect
to the claim, in addition to any other relief awarded, the prevailing
Party's reasonable attorneys' fees and other fees, costs, and expenses
of every kind.
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 21 of 27
21. WAIVER
The failure of either Party to assert a right under this Agreement or to
insist upon compliance with any term or condition of this Agreement shall
not constitute a waiver of that right or excuse a similar subsequent
failure to perform any such term or condition by the other Party. The
observance of any provision of this Agreement may be waived (either
generally or in any particular instance) only with the written consent of
the waiving Party.
22. AMENDMENTS.
No alteration or amendment of this Agreement, including change in the
Clinical Trial protocols or the Treatment Protocol, shall be valid unless
agreed to in writing by both Parties.
23. SEVERABILITY
The Parties agree that it is the intention of neither Party to violate any
public policy, statutory or common laws, and governmental or supranational
regulations; that if any sentence, paragraph, clause or combination of the
same is in violation of any applicable law or regulation, or is
unenforceable or void for any reason whatsoever, such sentence, paragraph,
clause or combinations of the same shall be inoperative and the remainder
of the Agreement shall remain binding upon the Parties.
24. FORCE MAJEURE
Neither Party shall be liable to the other in damages for, nor shall this
Agreement be terminable by reason of, any delay or default in such Party's
performance hereunder, if such delay or default is caused by conditions
beyond such Party's control including, but not limited to, acts of God,
war, insurrection, civil commotion, destruction of production facilities or
materials by earthquake, fire, flood or storm, labor disturbances including
strikes or lockouts, epidemic or failure of suppliers, public utilities or
common carriers. Each Party agrees to promptly notify the other Party of
any event of force majeure under this section 24 and to employ all
reasonable efforts toward prompt resumption of its performance hereunder
when possible if such performance is delayed or interrupted by reason of
such event.
25. NOTICES
25.1. All notices and other communications required or desired to be given
or sent by one Party to the other Party shall be in writing, in the
English language, and shall be deemed to have been given:
a. On the date of delivery, if delivered to the persons identified
below,
b. Five (5) calendar days after mailing if mailed, with proper
postage, by certified or registered airmail, postage prepaid,
return receipt requested, addressed as set forth below,
c. On the date of receipt if sent by telex or telecopy, and
confirmed in writing by the person identified in section 25.2,
below, or
d. Two (2) business days after delivered to an internationally
recognized overnight courier service marked for overnight
delivery.
25.2. Notices shall be addressed to the following addresses:
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 22 of 27
TO FFF: TO OMRIX:
FFF Enterprises, Inc. Omrix Biopharmaceuticals, Ltd
00000 Xxxxxx Xxxxxx Xxxxx XXX Xxxxx Xxxxxx,
Xxxxxxxx, XX 00000 Tel Hashomer Hospital,
Attn: Xxxxxxx X. Xxxxxxx, President Xxx Xxxx 00000 Xxxxxx
Attn: Xxxxxx Xxxx, President and CEO
Phone: (000) 000-0000
Fax: (000) 000-0000 Phone: x000 0 000 00 00
Email: xxx@xxxxxxxxxxxxxx.xxx Fax: x000 0 000 00 00
Email: xxxxxx.xxxx@xxxxx.xxx
With a copy to: With a copy to:
Xxxxx X. Xxxxxxx, Esq. Xxxxx Xxxxxxx, Adv.
Xxxxxxx Xxxxx & Xxxxx LLP Meitar, Liquornik, Geva & Leshem,
0000 Xxxx Xxxxxx Xxxxxxxxx
Suite 600 16 Abba Hillel Xxxxxx Xxxx
Xxxxxx, XX 00000 Ramat Gan 00000
Xxxxxx
26. ENTIRE AGREEMENT
This Agreement and the Supply and Distribution Agreement: Commercial Phase,
inclusive of all exhibits, constitutes the entire agreement between the
Parties with respect to the subject matter hereof and supersedes and
replaces all prior and contemporaneous agreements, understandings, writings
and discussions between the Parties. The Parties acknowledge and agree that
neither of the Parties is entering into this Agreement on the basis of any
representations or promises not expressly contained herein. It is agreed
that no usage of trade or other regular practice or method of dealing
between the Parties hereto shall be used to modify, interpret, supplement,
or alter in any manner the terms of this Agreement. This Agreement may not
be changed in any way except by an instrument in writing signed by both
Parties.
27. SURVIVAL OF CERTAIN PROVISIONS
The terms of any section of this Agreement that by their nature survives
termination or expiration of this Agreement shall survive the termination
or expiration of this Agreement, including without limitation sections 8
(Records), 10 (Confidentiality) 11 (Intellectual Property), 13
(Indemnification), 14 (Insurance), 17 (Limited Warranty; Limitation of
Liability), 19 (Governing Law and Venue), 20 (Dispute Resolution) and 25
(Notices).
[Signatures appear on following page.]
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 23 of 27
IN WITNESS WHEREOF, the authorized officers of the each of the Parties have
executed this Agreement by their signatures below.
OMRIX BIOPHARMACEUTICALS, LTD. FFF ENTERPRISES, INC.
By: /s/ Xxxxxx Xxxx By: /s/ Xxxxxxx X. Xxxxxxx
--------------------------------- ------------------------------------
Signature Signature
Name: Name: Xxxxxxx X. Xxxxxxx
------------------------------- Title: President
Title: Date: December 21, 2005
------------------------------
Date:
-------------------------------
EXHIBITS
Exhibit A. Supply and Distribution Agreement: Commercial Phase
Exhibit B. DCI Contract
Exhibit C. Treatment Protocol Pricing Sheet
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 24 of 27
EXHIBIT A
SUPPLY AND DISTRIBUTION AGREEMENT: COMMERCIAL PHASE
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 25 of 27
EXHIBIT B
DCI CONTRACT
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 26 of 27
EXHIBIT C
TREATMENT PROTOCOL PRICING SHEET
FFF - Omrix Agreement: Investigational Phase CONFIDENTIAL Page 27 of 27
