Exhibit 10.1
EXCLUSIVE MANUFACTURING, SUPPLY AND
DISTRIBUTION AGREEMENT
This EXCLUSIVE MANUFACTURING,
SUPPLY AND DISTRIBUTION AGREEMENT (this “Agreement”) is made and entered into as of 5:00 PM Eastern
Daylight Time, August 23, 2010 (the “Effective Date”) by and between Kamada Ltd., an Israeli corporation
(collectively with its Affiliates, “Kamada”), whose principal office is at Science Park, Kiryat Weizmann,
7 Sapir Street, P.O. Box 4081, Ness Ziona 74140, Israel, and Baxter Healthcare Corporation (“Baxter”),
a Delaware corporation whose principal office is at One Baxter Parkway, Deerfield, Illinois 60015, USA.
RECITALS
WHEREAS, Baxter
is in the business of developing, making, marketing and selling biopharmaceutical products, including human alpha-one antitrypsin,
also known as alpha-one protease inhibitor (“A1PI”);
WHEREAS, Kamada
owns certain intellectual property, confidential information, and regulatory licenses relating to the production of A1PI biopharmaceutical
products;
WHEREAS, Kamada
has developed the Product (as defined below) and desires to grant to Baxter the exclusive right to distribute and sell the Product
in the Baxter Territory in the Field (as each is defined below);
WHEREAS, Baxter
is willing to act as Kamada’s exclusive distributor for the Product in the Baxter Territory in the Field; and
WHEREAS, Kamada
and Baxter desire to enter into this Agreement to set forth the terms and conditions of such distribution right.
NOW, THEREFORE,
in consideration of the foregoing recitals and the mutual representations, warranties, covenants and agreements contained herein,
the Parties hereto agree as follows:
ARTICLE
1
DEFINITIONS
1.1 “Act”
shall mean the United States Food, Drug and Cosmetic Act and the regulations promulgated thereunder, as amended from time to time.
1.2 “Affiliates”
shall mean, with respect to either Party, those entities controlled by, in control of, or under common control with such Party.
A corporation or non-corporate business entity shall be regarded as in control of another corporation or business entity (a) if
it owns or directly or indirectly controls a majority of the voting stock or other ownership interest of the other entity, or (b)
in the absence of the ownership of a majority of the voting stock or other ownership interest of such entity, if it possesses,
directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate
business entity, as applicable.
1.3 “A1PI”
shall have the meaning set forth in the preamble.
1.4 “A1PI
IV Product” shall mean the Product and the Baxter Product (as such term is defined in the License Agreement).
1.5
“Affiliated Parties” shall mean, in respect of any specified Party, all Affiliates, directors,
officers, employees and Representatives of such Party.
1.6 “Approval
Payment” shall have the meaning set forth in Section 5.4(a).
1.7 “Baxter
Delivery Point” shall have the meaning set forth in Section 4.2(h)(i).
1.8 “Baxter
Facility” shall mean any facility owned by or on behalf of Baxter or an Affiliate of Baxter that is used to manufacture
A1PI IV Product.
1.9 “Baxter
Indemnified Parties” shall have the meaning set forth in Section 14.1.
1.10
“Baxter Product” shall have the meaning set forth in the License Agreement.
1.11 “Baxter
Territory” shall mean collectively the United States of America including its territories and possessions, Canada,
Australia and New Zealand.
1.12 “Best
Efforts” shall mean taking, in good faith, all required steps to achieve a particular result and to ensure that such
result is achieved as expeditiously as possible. Notwithstanding the foregoing, the utilization of ‘Best Efforts’ shall
not require a Party to: (a) take any actions that would, individually or in the aggregate, cause such Party to incur costs, or
suffer any other detriment, materially out of proportion to the benefits to be received by such Party under this agreement; (b)
take any actions that would, individually or in the aggregate, cause a material adverse change in such Party; (c) incur any material
liabilities; (d) dispose of any significant assets; (e) take any action that would violate any law or order to which the Party
is subject; (f) take any action that would imperil such Party’s existence or solvency; or (g) initiate any litigation or
arbitration.
1.13 “BLA”
or “Biologic License Application” shall mean a biologics license application filed with the FDA pursuant
to 21 C.F.R. § 601.2 et seq., or any foreign equivalent filed with the Regulatory Authorities in a country or territory to
obtain authorization to market A1PI IV Product in such country or territory.
1.14 “BLA
Party” shall mean, with respect to each BLA, the Party that owns or holds such BLA pursuant to Section 11.1.
1.15 “BLA
Supplement” shall mean a supplement to a BLA Application filed with the FDA pursuant to 21 C.F.R. § 601.2 et
seq., or any foreign equivalent filed with the Regulatory Authorities in a country or territory to modify or amend the referenced
BLA including, inter alia, to add a Baxter Facility to the BLA.
1.16 “CAPA”
shall have the meaning set forth in Section 11.3.
1.17 “cGMP”
shall mean the then-current Good Manufacturing Practices, 21 C.F.R. Parts 210 and 211.
1.18 “Claims”
shall have the meaning set forth in Section 14.1.
1.19 “Clinical
Data” shall have the meaning set forth in Section 8.2.
1.20 “Clinical
Studies” shall have the meaning set forth in Section 8.1(a).
1.21 “COA”
shall have the meaning set forth in Section 4.2(h).
1.22 “Commercially
Reasonable Efforts” shall mean the efforts and resources normally used by the relevant Party to carry out such activities
in a sustained manner consistent with the efforts such Party uses for products with similar market and profit potential and similar
scientific, technical, developmental and regulatory risks based on conditions then prevailing.
1.23 “Competitor”
shall mean any third party that operates in the blood plasma derivatives and/or plasma fractionation space.
1.24 “Competing
Product” shall mean an A1PI intravenous product produced for use in humans.
1.25 “Complaint”
shall mean any non-medical customer complaint associated with the Product. For the avoidance of doubt, “Complaint”
shall not include “adverse events,” which shall be addressed under a separate pharmacovigilance agreement between the
Parties.
1.26 “Confidential
Information” shall have the meaning set forth in Section 13.1.
1.27 “CPR”
shall mean the International Institute for Conflict Prevention & Resolution.
1.28 “Delivery
Point” shall have the meaning set forth in Section 4.2(h).
1.29 “Disclosing
Party” shall have the meaning set forth in Section 13.3.
1.30 “Effective
Date” shall have the meaning set forth in the preamble to this Agreement.
1.31 “Enforcement
Notice” shall have the meaning set forth in Section 14.7(b).
1.32 “Enforcement
Notice Period” shall have the meaning set forth in Section 14.7(b).
1.33 “Enhancement”
shall mean any improvements to the Product including, but not limited to, line extensions of the Product, packaging of the Product,
labeling of the Product, developments in the Product itself (including any new manufacturing processes or methods) and new applications
of the Product, in each case, in the Field.
1.34 “European
IV Transaction” shall have the meaning set forth in Section 17.1(a).
1.35 “Execution
Payment” shall have the meaning set forth in Section 5.4(a).
1.36 “Failure”
shall have the meaning set forth in Section 4.2(g)(ii).
1.37 “Failure
Costs” shall have the meaning set forth in Section 4.2(g)(iii).
1.38 “FDA”
shall mean the U.S. Food and Drug Administration and any successor agency thereto.
1.39 “Field”
shall mean the use of an A1PI concentrate produced from human plasma for intravenous administration in humans.
1.40 “Force
Majeure” shall have the meaning set forth in Section 18.4(b).
1.41 “Forecast”
shall have the meaning set forth in Section 4.2(a).
1.42 “ICH”
shall mean the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human
Use.
1.43 “Indemnified
Party” shall have the meaning set forth in Section 14.3.
1.44 “Indemnifying
Party” shall have the meaning set forth in Section 14.3.
1.45 “Inhaled
Product Transaction” shall have the meaning set forth in Section 17.1(a).
1.46 “Initial
Vials” shall have the meaning set forth in Section 4.2(a).
1.47 “Inspection
period” shall have the meaning set forth in Section 4.2(i).
1.48 “Intellectual
Property” shall mean all patents, trademarks, trade names, service marks, trade dress, trade secrets and copyrights,
including, without limitation, any renewal, extension or other rights therefor, and applications, provisionals, divisionals, reexaminations,
continuations in part, divisions, continuations, reissues, additions, substitutions and registrations for any of the foregoing
and all corresponding foreign patents and patent applications of each of the foregoing, technical information, devices, processes,
procedures, discoveries, techniques, formulae, software, designs, drawings, data, trade secrets, methods, protocols, products,
apparatuses and other materials, compositions, mask works, domain names, schematics, manufacturing processes, know-how, moral rights,
software programs or applications, manufacturing and production processes and techniques, research and development information,
drawings, specifications, designs, plans, proposals, technical data, financial and marketing plans, customer and supplier lists
and information, and all other intellectual property or proprietary rights.
1.49
“IV” shall mean intravenous or IV therapy, a method of introducing a liquid directly into a vein.
1.50 “Joint
Steering Committee” or “JSC” shall have the meaning set forth in Section 8.3.
1.51 “Kamada
Delivery Point” shall have the meaning set forth in Section 4.2(h)(ii).
1.52 “Kamada
Facility” shall mean any facility owned by or on behalf of Kamada or an Affiliate of Kamada that is used to manufacture
and supply A1PI IV Product.
1.53 “Kamada
Indemnified Parties” shall have the meaning set forth in Section 14.2.
1.54 “Kamada
Intellectual Property” shall mean all Intellectual Property related to or used in connection with or embodied in
the Product including, without limitation, the development, manufacture, processing, packaging, use or sale of the Product, but
shall not include any trademarks or tradenames used in connection with the Product solely outside of the Baxter Territory.
1.55 “Kamada
Territory” shall mean all territories not included in the Baxter Territory.
1.56 “Kamada
Trademarks” shall mean those trademarks owned by Kamada for A1PI concentrate prepared from human plasma for intravenous
administration registered in the Baxter Territory, expressly including the trademark GLASSIA™.
1.57 “Labeling”
shall have the meaning set forth in Section 4.3(a).
1.58 “Labeling
Quote” shall have the meaning set forth in Section 4.3(b).
1.59 “License
Agreement” means that certain Technology License Agreement by and between the Parties (or Affiliates thereof) dated
as of even date herewith.
1.60 “Market
Price” of each stock keeping unit (“SKU”) with respect to a particular year in a particular country shall
mean a price equal to the quotient obtained by dividing (a) the aggregate amount of Net Sales, of such SKU invoiced in such year
in such country by (b) the number of such SKUs listed in invoices included in such calculation of Net Sales.
1.61 “Minimum
Period” shall have the meaning set forth in Section 6.4(a).
1.62 “Minimum
Purchase Levels” shall have the meaning set forth in Section 6.4.
1.63 “Minimum
PV Information” shall mean the following data elements: a reporter who is identifiable by name, initials and/or address;
an identifiable patient/subject (i.e., identifiable by patient number, date of birth, age, or gender); at least one suspected substance/medicinal
product; at least one suspected adverse drug event.
1.64 “Minimums
Term” shall have the meaning set forth in Section 6.4(a).
1.65
“Net Sales” shall have the meaning set forth in the License Agreement; provided that gross revenues invoiced
shall include sales, leases or other transfers of both Baxter Products and Products by Baxter, its Affiliates, Permitted Commercialization
Sublicensees (as such term is defined in the License Agreement), agents and sub-distributors, to Unaffiliated Third Parties (as
such term is defined in the License Agreement) in the applicable country within the Baxter Territory.
1.66 “Non-BLA
Party” shall mean, with respect to each BLA, the Party that does not hold or own the BLA pursuant to Section 11.1.
1.67 “Non-Essential
Changes” shall have the meaning set forth in Section 4.3(b).
1.68 “No-Shop
Period” shall have the meaning set forth in Section 17.1.
1.69 “Packaging
Allowance” shall have the meaning set forth in Section4.3(b).
1.70 “Party”
shall mean Baxter or Kamada and “Parties” shall mean Baxter and Kamada.
1.71 “Paste”
shall mean Baxter’s fraction IV-1 (in the form of centrifuge paste or filter cake).
1.72 “Paste
Specifications” shall mean the specifications for Paste set forth in the Paste Supply Agreement.
1.73
“Paste Supply Agreement” shall mean that certain Amended and Restated Fraction IV-1
Paste Supply Agreement, dated as of the date hereof, by and between Baxter and Kamada.
1.74 “Prescription
Drug Marketing Act” shall mean the United States Prescription Drug Marketing Act of 1987 (P.L. 100-293, 102 Stat.
95) and its implementing regulations set forth in the U.S. Code of Federal Regulations (21 C.F.R. Part 205 and 21 C.F.R. Part 203).
1.75 “Product”
shall mean the Alpha 1-Proteinase Inhibitor for intravenous use (all IV dosage forms) produced by Kamada as further described by
the Specifications attached hereto. For the avoidance of doubt, the term ‘Product’ shall include all sizes and shapes
of the Product for uses in the Field, and any Enhancements to the Product.
1.76 “Product
Trademarks” shall have the meaning set forth in Section 4.3(c)(iii).
1.77
“Production Capacity” of 50 mL vials of Product for delivery to Baxter shall mean:
| Calendar Year |
|
50 mL vials/month |
| 2010 |
|
[*****] |
| 2011 |
|
[*****] |
| 2012 |
|
[*****] |
| 2013 |
|
[*****] |
| 2014 |
|
[*****] |
| 2015 |
|
[*****] |
1.78 “Quality
Agreement” shall mean that certain Quality Agreement between Kamada and Baxter executed in connection with the Parties’
respective obligations under this Agreement with respect to the Product, which shall include, without limitation, a joint Complaint
management process, storage and shipment conditions and controls, product release and environmental, temperature and humidity conditions
and controls, as well as roles and responsibilities in the change control process, each as applicable.
1.79 “Receiving
Party” shall have the meaning set forth in Section 13.3.
1.80 “Regulatory
Approval” shall mean, in any country in the world, the registrations, authorizations and approvals (including, but
not limited to approvals of New Drug Applications, Biologics License Applications, labeling and reimbursement approvals), licenses
(including, but not limited to, product and/or establishment licenses, manufacturing sites) supplements and amendments, pre- and
post-approvals, of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council
or other Regulatory Authority or governmental entity in such country (including the FDA), necessary for the development (including
the conduct of clinical trials), manufacture, distribution, importation, exportation, transport, storage, marketing, promotion,
offer for sale, use, or sale of a Product in such country.
1.81 “Regulatory
Authority” shall mean any national, supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity in such country (including the FDA) responsible for overseeing the development
(including the conduct of clinical trials), manufacture, distribution, importation, exportation, transport, storage, marketing,
promotion, offer for sale, use, or sale of a Product in such country.
1.82 “Regulatory
Documentation” shall mean those regulatory documents listed in the Technology Sharing Plan.
1.83 “Related
Agreements” shall mean the License Agreement the Paste Supply Agreement, the Quality Agreement and the Pharmacovigilance
Agreement.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
1.84 “Remedial
Action” shall have the meaning set forth in Section 11.3.
1.85 “Representatives”
shall mean the agents or advisors (including, without limitation, attorneys, accountants, consultants, bankers and financial advisors)
of Baxter or Kamada, as applicable.
1.86 “Restricted
Transaction” shall have the meaning set forth in Section 17.1.
1.87 “Sales
Personnel” shall have the meaning set forth in Section 7.2.
1.88 “Specifications”
shall mean the specifications for the Product, including the design, composition, output, product safety assurance, manufacture,
packaging, and/or quality control of the Product, as set forth on Exhibit 1.88 a preliminary draft of which is attached
hereto and a final version of which (such final version reflecting all changes recommended by the FDA) will be provided by Kamada
following approval by the FDA of the BLA for the Product and prior to the first shipment of the Product under this Agreement and
attached hereto and made a part hereof, as the same may hereafter be modified or updated by mutual agreement in writing. No changes
shall be made to the Specifications without the prior written consent of Baxter, which consent shall not be unreasonably withheld,
conditioned or delayed.
1.89 “Suspension
Conditions” shall have the meaning set forth in Section 2.1.
1.90 “Technology
Sharing Plan” shall have the meaning set forth in the License Agreement.
1.91 “Term”
shall have the meaning set forth in Section 15.1.
1.92 “Third
Party” shall mean any entity other than Kamada, Baxter, a Permitted Sublicensee (as such term is defined in the License
Agreement) of Baxter or their respective Affiliates, whether such Third Party is a person, company, corporation, limited liability
company, partnership or other legal entity, or a division or operating or business unit of such legal entity.
1.93 “Third
Party Rights” shall have the meaning ascribed thereto in Section 4.2(g)(ii).
1.94 “Transaction
Documents” shall mean, collectively, this Agreement and the Related Agreements.
1.95 “Transfer
Price” shall have the meaning set forth in Section 5.1(a).
1.96 “Upfront
Payment” shall have the meaning ascribed thereto in Section 5.4(a).
1.97 “US
BLA” shall have the meaning set forth in Section 11.1(a).
1.98
“US BLA Supplement” shall have the meaning set forth in Section 11.1(b).
ARTICLE
2
APPOINTMENT AS EXCLUSIVE DISTRIBUTOR
2.1 Scope.
(a) Effective as of
the Effective Date, Kamada hereby appoints Baxter as its sole and exclusive agent to market, sell, advertise, promote, import,
export and distribute, directly or through its Affiliates and/or sub-distributors, the Product in the Field in the Baxter Territory.
Baxter hereby accepts such appointment.
(b) If (i) Baxter
is required by law to permanently discontinue or (ii) Kamada and Baxter (after consideration of other reasonable manners in which
such activities may be continued) jointly determine in writing that Baxter should discontinue the marketing, sale or distribution
of the Product in the Baxter Territory due to changes in then-effective regulatory requirements for the Product (collectively,
the “Suspension Conditions”), then thirty (30) days after such legal requirement arises or the Parties
make such joint determination, and for such time as Baxter is required by law to discontinue or the Parties jointly determine that
Baxter should discontinue the marketing, sale or distribution of the Product in the Baxter Territory, Baxter shall not market,
sell or distribute the Product in the Baxter Territory; provided, however, that Baxter shall be permitted, to the extent permitted
by applicable law, to continue such activities for a reasonable period of time, not to exceed [*****], in order to wind down its
activities. If Baxter discontinues selling any and all Products as provided for in this Section 2.1(b), Baxter shall no
longer be obligated to fulfill any minimum purchase obligation/minimums. If the Suspension Conditions are removed or expire and
this Agreement has not been terminated prior to such time, Baxter shall be required to promptly resume all activities under this
Agreement as if such Suspension Conditions had never existed.
2.2 Exclusivity.
Kamada represents and warrants to Baxter that Kamada is not a Party to any other effective agreements, written or oral, with any
third party permitting the sale or distribution of the Product in the Field in the Baxter Territory, and Kamada covenants and agrees
that during the term, Kamada will not enter into any such agreement or itself, directly or indirectly, sell or distribute the Product
in the Baxter Territory. Commencing on the Effective Date, for a period of [*****] following the Effective Date (provided that
this Agreement has not otherwise been terminated), Kamada shall not promote, market or sell, directly or indirectly, in the Baxter
Territory any Competing Product.
2.3 Sub-distributors
and Subagents. Notwithstanding anything to the contrary in ARTICLE 3 below, Baxter may, in its sole discretion and without
the prior written consent of Kamada, appoint sub-distributors and/or subagents (including Baxter Affiliates and Affiliated Parties)
for distribution of the Product in the Baxter Territory; provided, however, that Baxter shall remain responsible for all obligations
hereunder.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
2.4 Resale
Prices. Baxter may sell the Product at such prices, as Baxter in its sole discretion, shall determine. Baxter shall recognize
100% of the income from its sales of Products.
ARTICLE
3
LICENSE
3.1 License.
Subject to the terms of this Agreement, Kamada hereby grants to Baxter and its Affiliates an exclusive, royalty-free right and
license, with the right to grant sublicenses, in the Field in the Baxter Territory under the Kamada Intellectual Property, that
is necessary or useful to enable Baxter to promote, import, export, use (in a manner consistent with the activities contemplated
by this Agreement or any Related Agreement), offer to sell, sell, have sold and distribute the Product in the Field in the Baxter
Territory under and in accordance with this Agreement. Kamada shall not grant any licenses under the Kamada Intellectual Property
to any Third Party to promote, import, export, use, offer to sell, sell, have sold or distribute any Competing Product in the Field
in the Baxter Territory.
ARTICLE
4
SUPPLY AND ORDERS FOR PRODUCT
4.1 Supply of
Product.
(a) Generally.
Subject to the terms of this Agreement, Kamada shall manufacture and supply to Baxter (including Baxter’s sub-distributors
and subagents (as applicable)) its requirements of Product, as requested by Baxter from time to time, for marketing, sale, re-sale,
import, export and use in the Field in the Baxter Territory in accordance with the terms of this Agreement. Unless Baxter is unable
to timely supply sufficient quantities of Paste meeting the Paste Specifications or unless otherwise agreed to in writing by Baxter,
all Product delivered to Baxter under this Agreement shall be manufactured solely from Paste supplied by Baxter pursuant to the
Paste Supply Agreement.
(b) Paste Supply
Agreement. The Parties acknowledge and agree that Kamada’s obligation to supply Product to Baxter under this Agreement
shall be subject to Baxter supplying sufficient quantities of Paste meeting the Paste Specifications in a timely fashion. Consequently,
Kamada shall not be deemed to be in breach of this Agreement to the extent that Kamada’s failure to comply with its obligations
under this Agreement directly results from: (A) Baxter’s failure to supply sufficient quantities of Paste meeting the Paste
Specifications in a timely fashion (unless Baxter has withheld delivery of Paste as a result of a material breach, by Kamada, of
the terms of the Paste Supply Agreement including, without limitation, payment of any amounts due thereunder) or (B) any material
delay in the fulfillment of Baxter’s obligations under the Paste Supply Agreement, including, but not limited to, as a result
of Kamada’s agreement to grant any extension or waiver of the terms of the Paste Supply Agreement in Baxter’s favor.
Further, all representations, warranties and covenants made by Kamada hereunder, the accuracy or fulfillment of which depends on
Baxter’s supply of sufficient quantities of Paste meeting the Paste Specifications, shall be deemed qualified such that if
sufficient quantities of Paste meeting the Paste Specifications are not supplied by Baxter in a timely fashion (subject again to
Baxter’s ability to withhold shipment of Paste as a result of Kamada’s material breach of the terms of the Paste Supply
Agreement) Kamada shall not be in breach of such representation or warranty or covenant and shall be granted an extension in fulfilling
such covenant for a period equal length to the delay caused by Baxter’s failure to deliver the corresponding Paste. Notwithstanding
the foregoing, Kamada shall be obligated to use Commercially Reasonable Efforts to obtain an alternative supply of paste for the
production of Product.
(c) Any Paste subject
to recall or withdrawal under the Paste Supply Agreement, shall be deemed to utilize Kamada’s Production Capacity, but shall
not be included in the calculation of Baxter’s Minimum Purchase Levels.
4.2 Purchase
of Product.
(a) Initial Vials.
Concurrent with the execution of this Agreement, Baxter shall issue a purchase order to Kamada for shipment of the initial approximately
[*****] vials (the “Initial Vials”) of Product for delivery no later than September 30, 2010; provided,
however that Baxter acknowledges and agrees that the shipment of Initial Vials of Product can only be made following receipt of
the FDA’s approval of their release. Baxter shall pay for such vials at the prices set forth in Section 5.1 and on
the other terms set forth herein.
(b) Forecasts.
At the beginning of each calendar month during the Term, Baxter shall provide Kamada in writing a good faith monthly forecast of
Baxter’s expected requirements for delivery of Product (consistent with the Specifications (including then current packaging
requirements)), for each month in the following [*****] period (each, a “Forecast”). Until [*****], the
first [*****] included in each such Forecast shall constitute a binding commitment on Baxter’s behalf to purchase the quantities
of Product set forth in such Forecast. Thereafter, the first [*****] included in each such Forecast shall constitute a binding
commitment on Baxter’s behalf to purchase the quantities of Product set forth in such Forecast. Except as provided in Section
6.4, Baxter shall not be obligated to purchase nor shall it have any liability in respect of the remaining [*****] of any Forecast.
Notwithstanding the foregoing, Baxter’s ability to modify the quantities set forth in the Forecast shall be limited by the
following:
(i) the forecasted
quantities for month [*****] may not vary by more than [*****] from the amount forecasted for [*****] in the immediately preceding
Forecast;
(ii) the forecasted
quantities for months [*****] may not vary by more than [*****] from the amounts forecasted for the corresponding previous month
(months [*****]) in the immediately preceding Forecast;
(iii) the
forecasted quantities for months [*****] may not vary by more than [*****] from the amounts forecasted for the corresponding
previous month (months [*****]) in the immediately preceding Forecast;
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(iv) until [*****],
the forecasted quantities for [*****] through [*****] may not vary by more than [*****] from the amounts forecasted for the corresponding
previous month (months [*****]) in the immediately preceding Forecast; and
(v) after [*****],
the forecasted quantities for [*****] may not vary by more than [*****] from the amounts forecasted for the corresponding previous
month ([*****]) in the immediately preceding Forecast.
Example 1: As
the new Forecast is submitted by Baxter, month [*****] in the current monthly Forecast would have been month [*****] in the previous
monthly Forecast. If the previous Forecast for month [*****] (when it was month [*****]) was [*****] vials, the quantity may be
increased to [*****] vials or decreased to [*****] vials.
Example 2 (after [*****]):
As the new Forecast is submitted by Baxter, month [*****] in the current monthly Forecast would have been month [*****] in the
previous monthly Forecast. If the previous Forecast for month [*****] (when it was month [*****]) was [*****] vials, the quantity
may be increased to [*****] vials or decreased to [*****] vials. This month (month [*****] is then part of the binding commitment,
and Baxter is obligated to purchase at least this quantity of vials.
(c) Orders.
Without derogating from Baxter’s obligations to purchase the quantities of Products set forth in the binding portion of the
Forecast pursuant to Section 4.2(b), from time to time, Baxter shall deliver binding purchase orders in accordance with
the Forecast for Product by written or electronic purchase order (or by any other means agreed to by the Parties) to Kamada. Kamada
shall either: (i) acknowledge and accept or (ii) reject any Baxter purchase order in writing within [*****] of receipt. The minimum
amount ordered per delivery shall be at least [*****] 50 mL vials. All such purchase orders shall be irrevocable. Purchase orders
shall set forth the desired date of delivery with respect to the Product ordered and shall be placed at least [*****] days prior
to such desired date of delivery. All Product ordered by Baxter under this Agreement shall be delivered on or before the delivery
date set forth in the applicable purchase order. Baxter acknowledges that except for the order for the Initial Vials, all orders
for delivery of Products to be provided by Baxter until March 31, 2011 shall be deemed automatically rejected by Kamada (and shall
not be counted toward the Minimum Purchase Levels) unless otherwise agreed by Kamada in writing or unless an agreement in writing
has been reached by the Parties on appropriate delivery dates for additional quantities Paste to address the manufacturing needs
for Product, due to the current shortage of sufficient Paste as of the Effective Date.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(d) Deemed Acceptance.
If (i) Kamada does not provide an acknowledgement to Baxter within [*****] of its receipt of a purchase order and (ii) the aggregate
quantities set forth in the purchase orders for delivery in the applicable month do not exceed the quantity set forth in the Forecast
(including the applicable variance set forth in Section 4.2(b)(iv)) for the corresponding month referred to in Section 4.2(b)
(unless Kamada has otherwise affirmatively agreed in writing to meet the excess quantities ordered), Kamada shall be deemed to
have accepted each purchase order from Baxter.
(e) Orders in Excess
of Production Capacity. Notwithstanding any other provision of this Agreement to the contrary, to the extent that the aggregate
purchase orders submitted by Baxter in any calendar month exceeds Kamada’s Production Capacity for such month, the excess
portion of such purchase orders shall not be binding or deemed accepted unless Kamada confirms the acceptance of such excess amount
in writing to Baxter.
(f) Shelf Life.
Upon delivery to Baxter or its designee in accordance with Section 4.2(h), the expiration date on each unit of Product shall
be: (i) a date that is at least [*****] months after the date of delivery, if delivery is made prior to the [*****] of the Effective
Date; (ii) a date that is at least [*****] months after the date of delivery, if delivery is made after [*****] of the Effective
Date but prior to the December 31, 2011; or (iii) if delivered thereafter, the greater of: (A) [*****] percent ([*****]%) of the
labeled shelf life of such unit of Product and (B) [*****]; provided that subject to Baxter's approval which will not be unreasonably
withheld, Kamada may deliver validation batches of Products which may have shorter shelf life than provided above.
(g) Failure to
Supply.
(i) In the event
of any supply shortage due to the [*****] or other circumstances [*****], Kamada shall [*****] of the Product in other fields and
territories [*****] to the last [*****] of aggregate sales of each such Party (until [*****] of the Effective Date, [*****] shall
be used to determine [*****]’s allocation).
(ii) If
Kamada fails to supply, for whatever reason (excluding events [*****] addressed by Section 4.1(b) above) directly or
through a third party, at least (A) [*****] of the aggregate purchase orders for Product that Kamada would be required to
fill under this Agreement over a period of [*****] or (B) [*****] of the aggregate purchase orders for Product that Kamada
would be required to fill under this Agreement over a period of [*****], and such failure to supply remains uncured (meaning
Kamada has failed to fully deliver all Product ordered pursuant to binding firm purchase orders during the relevant period)
for a period of [*****] or more consecutive days following the initial [*****] or [*****] period set forth above (a
“Failure”), Kamada shall, [*****], use its Best Efforts to, as soon as reasonably practicable,
[*****] that are Kamada’s responsibility. Further, upon the occurrence of a Failure, if any [*****]), Kamada shall also
use its Best Efforts to [*****] to allow Baxter to [*****] for the [*****] to the extent required to permit the [*****]
implementation of the [*****]. In addition, Kamada shall reasonably assist Baxter in the [*****] and shall make all necessary
[*****]. Baxter shall be relieved of its obligation under Section 6.4 for the duration of the Failure.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(iii) If, following
a Failure, Baxter in good faith [*****] directly arising from the [*****] in accordance with Section 4.2(g)(ii) above (collectively,
the [*****]), Baxter shall provide Kamada from time to time with a written summary of the [*****] along with such supporting detail
as may reasonably be requested in writing by Kamada. Until such time as [*****] has been [*****] for such [*****] shall be permitted
(but not obligated) to [*****] under the License Agreement an amount equal to the [*****]. Kamada agrees to not unreasonably withhold,
condition or delay its approval of [*****].
(h) Shipment.
(i) Until March
31, 2011. Until March 31, 2011, Kamada shall deliver the Product [*****] (Incoterms 2000) to airport location identified by
Baxter in the European Union (the “Baxter Delivery Point”), and title and all risk of loss shall
pass to Baxter [*****]. The Parties agree that the Baxter Delivery Point within Europe will be coordinated between the Parties
in order to assure Kamada's capabilities to comply with its obligations hereunder. [*****] shall arrange for shipping in compliance
with the applicable Product requirements regarding temperature, duration and other environmental factors as required to properly
preserve the Product without materially impacting its shelf life. [*****] shall pay for the cost of the carrier and the insurance
costs for delivery to the Baxter Delivery Point. Further, notwithstanding the use of the [*****] delivery term, [*****] shall be
responsible for all customs handling and duty charges and all other required licenses to import the product into the country where
the Baxter Delivery Point is located. Kamada acknowledges and agrees that Baxter does not and will not be obligated to accept any
product that is not released by the FDA Center for Biologics Evaluation & Research (CBER).
(ii) After March
31, 2011. After March 31, 2011, Kamada shall deliver the Product [*****] (Incoterms 2000) Kamada’s manufacturing facility
in Israel (the “Kamada Delivery Point”), and title and all risk of loss shall pass to Baxter [*****].
[*****] shall arrange for shipping in compliance with the applicable Product requirements regarding temperature, duration and other
environmental factors as required to properly preserve the Product without materially impacting its shelf life. [*****] shall pay
for the cost of the carrier and the insurance costs for delivery to the Kamada Delivery Point.
(iii) All Product
delivered by Kamada shall be suitably marked for delivery to such Baxter location as Baxter may designate. Kamada shall deliver
all Product to the Baxter Delivery Point or the Kamada Delivery Point (as applicable) in accordance with the reasonable instructions
specified in Baxter’s purchase orders. Kamada will deliver a pre-shipment notification to Baxter and Baxter’s designated
broker prior to initiating shipment. A Certificate of Analysis (“COA”), a form of which is attached hereto
as Exhibit 4.2(h), specific to testing of each lot/batch, must accompany each delivery. Kamada shall maintain a copy of
each such COA in compliance with cGMP. Kamada shall provide a duplicate copy of the COA, and a commercial invoice, and an airway
bill with each shipment to Baxter. In addition, Kamada, within [*****] of Baxter’s request, will provide a Certificate of
Origin to support documentation requirements related to the US-Israel Free Trade Agreement. Each shipment of Product shall have
appropriate temperature monitoring devices to ensure compliance with product temperature requirements. [*****] shall be responsible
for applying for batch release with the FDA and shall use Commercially Reasonable Efforts to obtain such release for enabling Kamada
to deliver released product to Baxter.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(i) Inspection
and Acceptance. Baxter shall have the right, at its sole discretion, to inspect each and every shipment of the Product. Baxter
shall have [*****] from receipt of each shipment of Product to visually inspect the shipment, the COAs and shipment records (“Inspection
Period”). Baxter may reject a shipment (or portion thereof) of Product if any one or more units contained therein
fail to conform to the Specifications, by providing Kamada written notice of such rejection prior to the end of the Inspection
Period. Baxter shall, upon receipt of written notice from Kamada, destroy or return the shipment of Product to Kamada; provided,
however, if Baxter has not received written instruction from Kamada within [*****] of its initial notice to Kamada, Baxter shall
return the shipment of Product to Kamada. In addition to the foregoing, for any Product for which the non-conformity identified
by Baxter is latent non-conformity that could not reasonably be detected upon visual inspection, Baxter shall have a period of
[*****] from the date of identification of such latent non-conformity to return to Kamada or destroy, as instructed by Kamada,
any such Product . Upon receipt of the nonconforming Product, Kamada will credit Baxter for the cost of returning the units of
Product, and replace such Product as soon as possible, taking into account Kamada’s Production Capacity at no additional
cost to Baxter and pay for all incremental transportation costs.
4.3 Product
Packaging and Labeling; Advertising and Promotional Labeling.
(a) Labeling Design.
As soon as reasonably practicable after Regulatory Approval (and thereafter as soon as reasonably practicable after any anticipated
change of any packaging material), the Parties shall come to a common agreement on the layout of the package insert and other elements
related to the packaging of the Product. Baxter shall be responsible for creating and/or designing the Product packaging, labeling
and instructions for use (collectively, the “Labeling”) for any Product purchased under this Agreement
for sale or distribution within the Baxter Territory; provided, however, that Kamada, as license holder for the Product in the
Territory, shall cooperate with Baxter to the extent reasonably requested by Baxter in the design of such Labeling. Baxter shall
deliver a mock-up of the proposed Labeling to Kamada for its review and comment prior to printing and Baxter shall in good faith
consider any comments received from Kamada.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(b) Costs.
Kamada shall be responsible for [*****] related to the sourcing and/or manufacturing of the Labeling to the extent [*****] for the Product packaging, labeling and instructions for use of the Product outside
the Baxter Territory from time to time [*****] (the “Packaging Allowance”). Baxter shall reimburse Kamada
[*****]. If, following completion of the initial Labeling design, Baxter requests changes
to the Labeling that are necessary to comply with regulatory and/or legal requirements or are specifically requested
by any applicable Regulatory Authority, Kamada shall promptly implement such changes to the Labeling and Baxter shall pay for [*****] such changes to the Labeling. If, following completion of the initial Labeling design, Baxter requests changes to the text or appearance
of the Labeling, which changes are not required pursuant to any regulatory or legal requirements or requested by
the applicable Regulatory Authority (“Non-Essential Changes”), then Kamada shall notify Baxter [*****] (collectively
the “Labeling Quote”). If, following receipt of the Labeling Quote, Baxter requests that Kamada proceed
with such Non-Essential Changes, Baxter shall be responsible for all [*****].
(c) Trademarks.
(i) Kamada grants
to Baxter a non-exclusive, royalty free license to use Kamada Trademarks for the sole purpose of marketing, offering for sale,
selling, having sold, advertising and promoting Products under this Agreement.
(ii) Kamada shall
be solely responsible for selecting, registering and enforcing Kamada Trademarks and, except as otherwise expressly set forth in
this Agreement, shall have sole and exclusive rights in and ownership of such Kamada Trademarks.
(iii) Baxter shall
be entitled to display Baxter’s name and logo, branding and trade dress, either as trademarks or trade names, on any packaging
material in accordance with the mutually agreed upon layout and design. Baxter shall have the right to develop trademarks for use
in marketing, offering for sale, selling, and having sold, advertising and promoting Products under this Agreement (“Product
Trademarks”). Baxter shall be solely responsible for selecting, registering and enforcing Product Trademarks and
shall have sole and exclusive ownership of them. Upon termination of this Agreement in its entirety or with regard to any country
in the Baxter Territory, Baxter shall promptly assign or cause to be assigned to Kamada all Product Trademarks that Baxter or any
of its Affiliates owns and/or has developed in any country within the Baxter Territory with respect to which this Agreement has
been terminated, unless: (A) Baxter has terminated this Agreement in whole or in part pursuant to Section 15.2(a) or 15.2(b),
(B) Baxter has marketed products that are not Products with such Product Trademark or (C) unless the License Agreement with respect
to such country is in effect. For the avoidance of doubt, if Baxter commercially uses a Product Trademark on one or more products
in addition to the Product, Baxter shall not be obligated to assign such trademark to Kamada.
(d) Baxter Promotional
Labeling. Baxter shall, with the assistance of Kamada as described herein, develop and use its own sales and promotional literature
in connection with its marketing and distribution of the Product. Baxter shall be responsible for ensuring that the text of all
Product labeling, packaging and promotional literature developed and used solely by Baxter, its Affiliates and sub-distributors
is in compliance in all material respects with the Act and other applicable laws, rules and regulations.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(e) Regulatory
Submissions. The BLA-Party shall be responsible for submitting all advertising and promotional labeling to the FDA Division
of Drug Marketing, Advertising, and Communications as well as submission to the FDA of the required annual report, as well as any
similar activity with respect to any Regulatory Authority throughout the Baxter Territory. Notwithstanding the foregoing, Baxter
agrees that, upon the reasonable request of Kamada, it shall act as Kamada’s agent with respect to the submission of such
advertising and promotional labeling. Details relating to the foregoing roles and responsibilities shall be more precisely described
in the Quality Agreement between the Parties. Kamada shall have the right to review, approve, reject or modify any submissions
to the FDA prepared by Baxter as Kamada's agent in the United States.
4.4 Additional
Quantities. During [*****], the Parties shall meet in good faith and discuss Kamada’s ability to provide up to an additional
[*****] 50 mL vials of Product in the aggregate for the period between [*****] and [*****]. Pricing for such units shall as set
forth in Section 5.1.
4.5 Post-2015
Forecasting. Baxter shall notify Kamada in writing no later than June 30, 2013 with respect to its expectations for the
continued supply of Product by Kamada for calendar years 2015 and beyond. Notwithstanding anything contained in Section 6.4
to the contrary, Baxter shall be entitled to eliminate any Minimum Purchase Levels for calendar year 2015 no later than June 30,
2013. If Baxter elects to eliminate the Minimum Purchase Levels for calendar year 2015 then, notwithstanding anything to the
contrary in the License Agreement, Baxter shall begin paying the Minimum Royalty effective in calendar year 2015.
ARTICLE
5
PRICES AND PAYMENTS
5.1 Price.
(a) The transfer price
(the “Transfer Price”) of each 50 mL vial of Product shipped by Kamada to Baxter each calendar year of
the Term shall, subject to adjustment as per the provisions of Sections 5.1(b) and 5.1(d) below and the other applicable
provisions of this Agreement, and with such Transfer Price taking into consideration the Upfront Payments set forth in Section
5.4(a) be equal to the prices set forth in the following table:
[*****]
(b) Quantities
Between Price Points. In the event the quantity of vials of Product purchased in a calendar year falls between the numbers
in the column titled “Annual Quantity of 50 mL Vials” the Transfer Price of each 50 mL vial of Product shipped by Kamada
to Baxter in such calendar year in the Term shall be determined according to a linear calculation between each two numbers, such
that the Transfer Price for a hypothetical annual purchase of [*****] vials of Product by Baxter would be [*****].
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(c) Base Transfer
Price; Annual True Up. During each calendar year and subject to Section 5.1(d) below, the price to be invoiced by Kamada
for all vials of Product purchased by Baxter at any time during a given calendar year shall be determined based upon the actual
quantities of vials of Product purchased in such applicable calendar year (if any) plus the Product to be purchased by Baxter under
both the binding and non-binding part of the Forecast for the remaining months of such calendar year (the “Base Transfer
Price”) as adjusted from time to time to reflect any increases or decreases (as applicable) in such Forecast. At
the conclusion of each calendar year during the Term, the Parties shall determine, based upon the number of vials of Product actually
purchased by Baxter during such calendar year, the applicable Transfer Price as calculated pursuant to the above table/formula
and Section 5.1(d). If the applicable Transfer Price is [*****], Kamada shall [*****] equal to the difference between the
[*****] multiplied by the [*****]. The [*****] of Product by Baxter or if the Agreement has been terminated [*****]. If the calculated
[*****] than the [*****], Kamada shall [*****] and [*****] of such [*****] in accordance with Section 5.2 below.
(d) Annual and
Market Price Adjustments.
(i) Beginning [*****]
and on each January 1 thereafter during the Term, the then-current Transfer Prices (taking into account any prior year adjustments
and Market Price adjustments) shall be increased by [*****] of: (A) [*****] and (B) the percentage increase, if any, in the Producer
Price Index (as published by the U.S. Bureau of Labor Statistics) over the prior year.
(ii) If, during
any calendar year, the Transfer Price identified above is, at any time, less than [*****] of the average Market Price for the Product
for the applicable calendar year, the applicable Transfer Price shall be increased when calculating the final Transfer Price for
Product in the annual true-up at the conclusion of each calendar year during the Term to be equal to [*****] of such average Market
Price.
5.2 Invoicing;
Payment. Kamada shall submit a detailed invoice to Baxter for each shipment of Product ordered by Baxter under this Agreement.
Each invoice shall be due and payable [*****] days from the date Baxter’s receipt of the invoice. All invoices shall be sent
to Baxter’s address for notice purposes, or such other address as requested by Baxter in writing, without regard to the actual
shipping address for the Product. Each such invoice shall state Baxter’s aggregate and unit purchase price for the Product
in the relevant shipment, plus any freight incident to the purchase or shipment initially paid by Kamada and to be borne by Baxter
hereunder.
5.3 Taxes.
All amounts due to Kamada hereunder shall not be reduced by [*****], provided, however, that Baxter shall [*****] similar mandatory governmental charges levied by any governmental jurisdiction [*****]. Baxter and
Kamada will cooperate in obtaining any necessary documentation required under applicable tax law, regulation, or intergovernmental
agreement.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
5.4 Upfront
Payment.
(a) In consideration
of the undertakings by Kamada pursuant to this Agreement and the appointment of Baxter as the exclusive distributor for the Product
in the Field in the Baxter Territory, Baxter agrees that it shall, within ten (10) days of the execution of this Agreement pay
to Kamada an amount equal to Twenty Million Dollars (USD $20,000,000)) (the “Upfront Payment”) representing
prepayment of a portion of the Transfer Price as set forth in Section 5.1.
(b) [*****].
(i) In
the event a Failure occurs within the [*****] from the date of first commercial delivery of Product
from Kamada to Baxter and Baxter has waived its right to accelerate implementation of the Technology Sharing Plan in accordance
with Section 4.2(g), then Baxter shall have the right to terminate this Agreement
with immediate effect by giving Kamada written notice, such termination right to be exercised prior to the earlier to occur of
(A) [*****] days after the expiration of the aforesaid [*****] period, or (B) Kamada’s cure of such Failure. [*****]
(ii) If
Baxter terminates this Agreement pursuant to Section 15.2(c)(ii) within the first [*****]
from the date of first commercial delivery of Product from Kamada to Baxter, then [*****]
5.5 Currency
of Payments. All payments due under this Agreement shall be made in U.S. Dollars by electronic funds transfer to such bank
account as the receiving Party may designate from time to time.
5.6 Books,
Records and Audit Rights.
(a) Kamada Audit
of Baxter. Baxter and its respective Affiliates (as applicable) shall maintain accurate books and records regarding sales of
the Product in accordance with U.S. generally accepted accounting principles consistently applied by Baxter in sufficient detail
to enable Kamada to monitor compliance by Baxter with the terms of this Agreement. Additionally, in the event of a Failure and
an election by Baxter to manufacture the Product itself, Baxter and its respective Affiliates shall maintain accurate books and
records regarding its actual manufacturing costs. Baxter shall maintain or cause to be maintained such books and records for a
period of [*****] years following the applicable activity. Kamada shall have the right to inspect such books and records for the
purpose of verifying the payments provided for in this Agreement for the preceding [*****] years and, if applicable, the calculation
of actual manufacturing costs as contemplated under Section 4.2(g)(iii), at reasonable intervals (but no more frequently
than once in any [*****] month period) and upon not less than [*****] days prior written notice. Upon receipt of written notice,
Baxter and Kamada shall confer to agree upon an acceptable date for the audit, taking into account normal activities of Baxter’s
finance function (e.g., quarter end and year end activities). Such inspections shall be performed by an independent certified public
accountant selected by Kamada and reasonably acceptable to Baxter. All expenses related to such inspection shall be borne by Kamada;
provided that if any such inspection reveals any underpayment by Baxter to Kamada in respect of any year of the Agreement in an
amount exceeding [*****] of the amount actually paid by Baxter to Kamada in respect of such year then Baxter shall (in addition
to paying Kamada the shortfall), bear the costs of such inspection. Any deficiencies in payment or, if applicable, overcharge for
actual manufacturing costs shall be immediately due and payable by Baxter to Kamada. Any independent certified public accountant
engaged by Kamada to conduct the audit pursuant to this Section 5.6 shall sign a confidentiality agreement acceptable to
Baxter or prior to any such audit and shall only report those findings of the examination to Kamada as are necessary to validate
that payments are tracked, calculated and made or, if applicable, actual manufacturing costs were calculated in accordance with
this Agreement.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(b) Baxter Audit
of Kamada. Kamada and its Affiliates shall maintain accurate books and records regarding all financial matters pertaining to
this Agreement including all costs incurred by Kamada for which it seeks reimbursement from Baxter, in accordance with applicable
local standards consistently applied by Kamada in sufficient detail to enable Baxter to monitor compliance by Kamada with the terms
of this Agreement including, but not limited to, Section 4.3. Kamada shall maintain such books and records for a period
of [*****] following the applicable activity. Baxter shall have the right to inspect such books and records for the purpose of
verifying the payments provided for in this Agreement for the [*****], at reasonable intervals (but no more frequently than once
in any [*****] period) and upon not less than sixty [*****] prior written notice. Upon receipt of written notice, Baxter and Kamada
shall confer to agree upon an acceptable date for the audit, taking into account normal activities of Kamada’s finance function
(e.g., quarter end and year end activities.) Such inspections shall be performed by an independent certified public accountant
selected by Baxter and reasonably acceptable to Kamada. All expenses related to such inspection shall be borne by Baxter; provided
that if any such inspection reveals any underpayment by Kamada to Baxter in respect of any year of the Agreement in an amount exceeding
[*****] of the amount actually paid by Kamada to Baxter in respect of such year then Kamada shall (in addition to paying Baxter
the shortfall), bear the costs of such inspection. Any deficiencies in payment by Kamada shall be immediately due and payable by
Kamada to Baxter. Any independent certified public accountant engaged by Baxter to conduct the audit pursuant to this Section
5.6 shall sign a confidentiality agreement acceptable to Kamada prior to any such audit and shall only report those findings
of the examination to Baxter as are necessary to evidence that records were or were not maintained and used in accordance with
this Agreement.
5.7 Interest.
All amounts not paid when due under this Agreement (excluding any amounts that are disputed and ultimately resolved in favor of
the disputing party) shall bear interest at the rate of [*****], or, if less, the highest rate allowable by applicable
law, from the due date until the date of payment.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
ARTICLE
6
ADDITIONAL RIGHTS AND OBLIGATIONS OF BAXTER
6.1 Sales
and Marketing.
(a) Baxter shall at
all times during the Term of the Agreement use Commercially Reasonable Efforts to advertise, promote, market, sell and distribute
the Product in the Baxter Territory in the Field, provided that such Commercially Reasonable Efforts shall not require Baxter to
direct any efforts towards conversion from its existing products to the Product.
(b) Baxter shall,
at its sole expense, be responsible for the preparation of all sales and marketing materials (excluding Labeling except to the
extent in excess of the Packaging Allowance) for the marketing and sale of the Product. However, Baxter and Kamada will meet no
less than annually to review commercialization-related plans (other than pricing) and materials and Kamada will cooperate with
Baxter in the preparation of Baxter’s sales and marketing materials.
(c) Each Party shall
seek the other Party’s input and shall in good faith consider the other Party’s comments on any matters expected by
the other Party to affect the product label, indications or Regulatory Approvals for the Product in the Baxter Territory.
6.2 Package
Labeling and Other Product Related Materials. Baxter shall, consistent with Section 4.3 [*****] design promotional brochures
and other material suitable for marketing the Product, provided, however that Baxter shall, in a manner as reasonably requested
by Kamada, so long as such request is consistent with any applicable regulatory requirements, identify Kamada as the manufacturer
of the Product. In connection with the foregoing, Kamada shall furnish Baxter with technical and quality related data sheets, as
well as any other supporting materials for the Product.
6.3 Certain
Restrictions. Except as otherwise permitted by written agreement of the Parties, Baxter shall not, and Baxter shall use Commercially
Reasonable Efforts to ensure that its Affiliates and sub-distributors shall not, directly or indirectly (a) promote, sell or transfer
any Product outside the Baxter Territory or (b) knowingly promote the Product for any use outside of the Field or for any indication
not specifically set forth in a Regulatory Approval for the Product. Kamada acknowledges that, notwithstanding the foregoing covenants
and agreements, Baxter cannot control use of the Product after sale, and Baxter makes no representations or warranties regarding
how a Product may ultimately be used.
6.4 Minimum
Purchase Levels.
(a) During each calendar
year following the Effective Date (each a “Minimum Period”), for a period terminating on December 31,
2015 (the “Minimums Term”), Baxter shall be obligated to purchase minimum volumes (the “Minimum
Purchase Levels”) of the Product as follows:
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
|
Minimum Period
(Calendar Year) |
|
Minimum Purchase Levels
(50 mL vials) |
| 2010 |
|
[*****] |
| 2011 |
|
[*****] |
| 2012 |
|
[*****] |
| 2013 |
|
[*****] |
| 2014 |
|
[*****] |
| 2015 |
|
[*****] |
(b) After the Minimums
Term, and during the remaining Term of this Agreement, Baxter shall not be obligated to meet any minimum purchase levels for the
Product.
ARTICLE
7
ADDITIONAL RIGHTS AND OBLIGATIONS
7.1 Compliance
with Laws; Manufacturing.
(a) Kamada shall comply
in all material respects with all applicable laws, rules and regulations applicable to the design, manufacture, labeling, packaging,
storage and handling of the Product in the Baxter Territory, including maintaining qualified manufacturing and quality facilities
and/or procedures. The content of the labeling or any packaging inserts shall remain the responsibility of Baxter as provided in
Sections 4.3, 6.1 and 6.2. Kamada shall ensure that all third party manufacturers of any raw materials for
the Product comply in all material respects with all laws, rules and regulations applicable to the design, manufacture, labeling
and packaging of the Product in the Baxter Territory. Without limiting the generality of the foregoing, Kamada (and all third party
manufacturers of any raw materials for Product) shall implement such quality control systems and procedures as shall be appropriate
to ensure compliance with the requirements of cGMP and ICH that are applicable to Kamada (or any third party manufacturer) as the
manufacturer and supplier of the Product. Kamada shall allow reasonable access to its records, manufacturing facilities, and its
third party manufacturers’ manufacturing facilities and records (if applicable) to allow Baxter and any Regulatory Authority
to conduct full compliance audits or inspections relating to the Product. Further, the Parties shall make Commercially Reasonable
Efforts to, within sixty (60) days following the Effective Date but in any event prior to the sale of any Product by Baxter to
third parties, enter into a Quality Agreement in accordance with applicable cGMP and ICH requirements and regulations, which shall
include, without limitation, a Complaint management process, storage and shipment conditions and controls, product release and
environmental, temperature and humidity conditions and controls, as well as roles and responsibilities in the change control process,
each, as applicable. Kamada and any third party manufacturer engaged by Kamada shall ensure that the Products are manufactured
in strict compliance with the Specifications.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(b) Baxter shall comply
in all material respects with all laws, rules and regulations applicable to the labeling, packaging inserts, storage and handling
of the Product in the Territory, including maintaining qualified quality facilities and procedures. Baxter shall ensure that all
Affiliates and sub-distributors shall implement such quality control systems and procedures as shall be appropriate to ensure compliance
with the requirements of cGMP and ICH that are applicable to Baxter (or any Affiliate or sub-distributor) as the distributor of
the Product. Baxter shall allow, and shall procure that its Affiliates and sub-distributors shall allow, reasonable access to their
applicable manufacturing facilities and records to allow Kamada and any Regulatory Authority to conduct full compliance audits
or inspections relating to the storage, sale or distribution of the Product.
7.2 Training
and Support. Kamada shall, at [*****] expense, provide to Baxter copies of all available technical materials (including clinical
study reports and summaries) and such other materials, information and knowledge that are owned by Kamada and in Kamada’s
control or possession as are necessary to train sales personnel of Baxter, its Affiliates and sub-distributors in the Baxter Territory
(the “Sales Personnel”). Baxter shall be entitled to duplicate, reproduce and distribute such materials
to the extent necessary or useful in conducting training of the Sales Personnel. Baxter shall be responsible, at its sole cost
and expense, for training all Sales Personnel.
7.3 Samples;
Patient Assistance Program Participation.
(a) Upon reasonable
prior written notice and subject to the availability of sufficient quantities of such Products, Kamada shall use Commercially Reasonable
Efforts to supply Baxter with reasonable quantities of Product not fit for commercial sale, free of charge, for Baxter’s
use as demonstration Product. Further, Kamada shall use Commercially Reasonable Efforts to supply Baxter with reasonable quantities
of empty but labeled vials, and other labeling and packaging materials at Kamada’s actual cost therefor. Baxter and its Affiliates
and sub-distributors shall provide all such samples to customers and/or patients in accordance with applicable laws, including,
but not limited to, the United States Prescription Drug Marketing Act.
(b) Until the First
Commercial Sale (as defined in the License Agreement) and upon reasonable prior written notice, Kamada shall supply Baxter with
up to an aggregate amount, together with the Product supplied under Section 8.1(b)(iii), [*****] 50 mL vials of Product
during the Term of this Agreement to be provided by Baxter to patients participating in Baxter’s patient assistance program
and Baxter’s physician sampling program. All quantities of Product provided under this Section 7.3(b) shall be at
a price [*****] vial and shall count towards Kamada’s Production Capacity but not towards the Minimum Purchase Levels.
7.4 Sales
Leads. Kamada shall promptly forward to Baxter all leads for sales of Product in the Field in the Baxter Territory, and Baxter
shall promptly forward to Kamada all leads for sales of Product in the Field in the Kamada Territory.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
ARTICLE
8
PRODUCT DEVELOPMENT ACTIVITIES
8.1 Clinical
Studies.
(a) Conduct of
Studies. Baxter shall conduct the post-marketing clinical studies required by Regulatory Authorities for the Product in the
Field in the Baxter Territory which shall follow the clinical study plan which shall be attached hereto as Exhibit 8.1(a)
(collectively, the “Clinical Studies”). Promptly following the execution of this Agreement, the Parties
shall meet in good faith to draft Exhibit 8.1(a) based upon input from both of the Parties and the FDA (as applicable)
and complete such exhibit as promptly as possible. Upon completion of the exhibit, it shall be acknowledged as the final exhibit
in writing by both Parties and at such time shall be attached hereto and incorporated herein by reference. Kamada shall be obligated
to use its Best Efforts to provide the related support required for Regulatory Approval for the continued marketing of the Product
in the Baxter Territory. In connection therewith, the Parties shall at all times during the conduct of the Clinical Studies keep
each other reasonably informed of all activities thereunder, and consult with each other as reasonably requested by the other Party.
The JSC (as hereinafter defined) shall determine each Party’s responsibilities with respect to all Clinical Studies, provided
that Baxter shall be responsible for the conduct of all Clinical Studies. Baxter shall comply with all laws and regulations applicable
to the conduct of such Clinical Studies.
(b) Funding of
Studies.
(i) Subject to Section
8.1(b)(iii), Baxter shall be responsible for the costs and expenses of all Clinical Studies required to obtain Regulatory Approval
under Section 8.1(a). Once Baxter has spent an aggregate amount equal to [*****] relating
to such Clinical Studies, Baxter shall have the right [*****] of any subsequent costs
and expenses related to such Clinical Studies [*****]: (A) future royalty payments under the License Agreement, (B) product purchases
and/or (C) Milestone Payments under the License Agreement that may be due to Kamada up to an aggregate [*****]
amount of [*****].
Thereafter, Baxter shall be responsible for all Clinical Study expenses. Notwithstanding the foregoing, no amount shall be [*****]
with respect to any expenses incurred by Baxter prior to [*****], and Baxter shall use good faith
efforts to ensure that any [*****] are made in amounts of similar magnitude with the object being that (given the information
available to the Parties relating to the aggregate costs expected to be incurred for the Clinical Studies) the [*****] is not reached for a period of at least [*****] following the date on which Baxter
begins to incur expenses that are eligible for [*****].
(ii) Kamada agrees
that it shall reasonably cooperate with Baxter if Baxter determines it will seek Regulatory Approval for additional indications
for the Product; provided, however, that the foregoing shall not obligate Kamada to undertake any material expenditures unless
otherwise agreed by the Parties in writing. Kamada shall be responsible for the costs and expenses of all clinical studies initiated
by Kamada that are neither approved by the Joint Steering Committee nor requested by a Regulatory Authority in the Baxter Territory,
and shall own all data derived therefrom.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(iii) Until the
First Commercial Sale (as defined in the License Agreement) and an in connection with the conduct of the Clinical Studies Kamada
shall supply Baxter with up to an aggregate amount, together with the Product supplied under Section 7.3(b), [*****] 50 mL
vials of Product during the Term of this Agreement to be utilized solely in the conduct of such Clinical Studies. All quantities
of Product provided under this Section 8.1(b)(iii) shall be at a price of [*****] vial and shall count towards Kamada’s
Production Capacity but not towards the Minimum Purchase Levels.
8.2 Ownership
and Use of Clinical Data. Baxter shall be the owner of all data and information generated by and in connection with the Clinical
Studies and Baxter initiated post-marketing studies including data analysis and clinical study reports (collectively, the “Clinical
Data”) for use in the Field in the Baxter Territory. Baxter shall have the right during the Term to use all data
from the Clinical Studies and Baxter initiated post-marketing studies in connection with its performance of its obligations under
this Agreement. Notwithstanding the foregoing, Kamada shall have the right to use all Clinical Data for use in registering, developing
or marketing the Product in the Kamada Territory and, upon termination of this Agreement, except for early termination by Baxter
in accordance with Section 15.2(a) or Section 15.2(b), the Baxter Territory, and Baxter hereby grants to Kamada an
irrevocable, perpetual, royalty-free license to all rights related to such data.
8.3 Joint
Steering Committee. The Parties will establish a joint steering committee (“Joint Steering Committee”
or “JSC”) to manage the relationship of the parties under the Transaction Documents. The structure, scope
of responsibility and authority of the JSC shall be as set forth in Exhibit 8.3.
ARTICLE
9
PRODUCT WARRANTIES
9.1 Warranty.
Kamada warrants that, as of the time of delivery by Kamada to Baxter of the Product in accordance with this Agreement, all Product
will (a) be free of defects in design, material and workmanship and conform to the Specifications, (b) comply in all material respects
with all applicable safety, health and other laws, rules and regulations applicable to the Product in the Baxter Territory, and
(c) not be adulterated or misbranded as defined in the Act, except in the case of clause (a) through (c) above to the extent arising
from the portion of the content of labels designed by Baxter or from Paste delivered by Baxter to Kamada that fails to conform
to the Paste Specifications or from the product handling or storage practices of Baxter. This warranty shall not apply, and Kamada
shall be under no obligation to repair or replace Products or under any liability to Baxter of any nature, in relation to Products
that are not properly handled or stored by Baxter or are promoted by Baxter for a use other than in accordance with the package
insert.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
9.2 Non-Conforming
Product. In the event that any Product purchased hereunder fails to conform to the warranties set forth in Section 9.1,
Kamada, at its option, will either replace the defective or non-conforming Product at its expense or fully refund the purchase
price plus reasonable shipping, insurance and other transportation charges incurred by Baxter. The foregoing shall not be Baxter’s
sole and exclusive remedy with respect to non-conforming Product and all other remedies at law or in equity shall remain available
to Baxter, subject to Section 14.6.
9.3 Product
Liability.
(a) Kamada shall be
responsible for all claims related to the Product to the extent arising from (i) the gross negligence or willful misconduct of
Kamada in the performance of its obligations hereunder, (ii) a material breach of this Agreement by Kamada, including a breach
of any of the representations or warranties set forth in Section 9.1 and/or Section 10.1, or (iii) a material
breach of any law or regulation (that Kamada is required to comply with by nature of its obligations hereunder) by Kamada.
(b) Baxter shall be
responsible for claims related to the Product to the extent arising from: (i) the gross negligence or willful misconduct of Baxter
in the performance of its obligations hereunder, (ii) material breach of this Agreement by Baxter or (iii) material breach of any
law or regulation (that Baxter is required to comply with by nature of its obligations hereunder) by Baxter, including, but not
limited, to material breach of laws or regulations related to the conduct of clinical trials for the Product and the storage and
shipment of Products.
9.4 Disclaimer
of Warranties. Except for those warranties expressly set forth in Section 2.2, Section 9.1 and ARTICLE
10 of this Agreement, neither Party makes any warranties, written, oral, express or implied, with respect to the Product or
the development and production of the Product. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED. NO WARRANTIES OF
KAMADA MAY BE CHANGED BY ANY REPRESENTATIVES OF EITHER PARTY EXCEPT IN A WRITING SIGNED BY BOTH PARTIES.
ARTICLE
10
REPRESENTATIONS, WARRANTIES AND COVENANTS
10.1 Kamada’s
Representations, Warranties and Covenants. Kamada hereby represents and warrants (or covenants, as applicable) to Baxter that
as of the Effective Date and during the Term:
(a) Kamada is a corporation
duly organized, validly existing under the laws of Israel, and this Agreement has been duly authorized by all necessary corporate
action.
(b) Kamada has all
necessary corporate power and authority to enter into this Agreement and to perform all of its obligations hereunder.
(c) This Agreement
has been duly authorized, executed and delivered by Kamada and is the legal, valid and binding obligation of Kamada, enforceable
against Kamada in accordance with its terms.
(d) Neither the execution,
delivery and performance by Kamada of this Agreement nor the consummation of the transactions contemplated hereby violate or conflict
with the charter documents of Kamada, any material contract, agreement or instrument to which Kamada is a party or by which it
or its properties are bound, or any judgment, decree, order or award of any court, governmental body or arbitrator by which Kamada
is bound, or any law, rule or regulation applicable to Kamada.
(e) As of the Effective
Date, no actions are threatened or pending before any court or governmental agency or other tribunal relating to any of the Products.
(f) Kamada is not
under any obligations inconsistent with the provisions of this Agreement.
(g) Subject to Section
4.1(b), all Product manufactured by Kamada and sold under this Agreement will have been manufactured, labeled (disregarding
that portion of the Product label designed by Baxter), packaged (disregarding that portion of any Product packaging designed by
Baxter) and delivered to Baxter in accordance with the Specifications and all applicable international, federal, state and local
laws and regulations including, but not limited to, the Act and cGMP.
(h) All Product manufactured
by Kamada and sold under this Agreement is guaranteed as of the time of delivery to Baxter, to be not adulterated or misbranded
within the meaning of the Act, and not an article which may not under the provisions of the Act be introduced into interstate commerce.
Additionally, no Product delivered pursuant to this Agreement will, at the time of such delivery, be adulterated or misbranded
within the meaning of the Act, or within the meaning of any applicable law in which the definition of adulteration is substantially
the same as that contained in the Act, as such Act and such laws are constituted and effective at the time of such delivery nor
will such Product be an article which may not, under the provisions of the such Act, except those relating to misbranding, be introduced
into interstate commerce.
(i) Each lot of Product
delivered to Baxter will at the time of delivery to Baxter have the applicable shelf life set forth in Section 4.2(f) and
will , subject to Section 4.1(b), be free from defects in materials and workmanship.
(j) The manufacturing
facilities and processes utilized for the manufacture of the Products will, at all times during the Term of this Agreement, comply
with all applicable FDA regulations and similar applicable foreign regulations including, without limitation, applicable cGMP.
(k) To Kamada’s
knowledge, Kamada and all Product delivered under this Agreement are in material compliance with all applicable environmental,
health, safety and transportation regulations (including, but not limited to, regulations of the U.S. Environmental Protection
Agency, U.S. Occupational Safety and Health Administration, and the U.S. Department of Transportation).
(l) To Kamada’s
knowledge, each material item of environmental, health and safety information, including but not limited to, all MSDSs, related
to the Product or Kamada supplied by Kamada under this Agreement shall be complete and accurate in all material respects on the
date on which it is supplied to Baxter.
(m) Kamada owns all
of the rights, title and interest in and to the Kamada Intellectual Property that is necessary for Kamada to enter into this Agreement
and perform its obligations hereunder.
(n) Kamada has not
received any communication (verbal or otherwise) from any third party alleging that the Product or the manufacturing process used
for the Product infringes any third party Intellectual Property rights.
(o) Kamada shall,
throughout the Term of this Agreement and for a period of [*****] thereafter, maintain a system that is capable of tracking all
source materials for the Product and shall, upon request, provide all such data to Baxter and the applicable Regulatory Authorities.
Within sixty (60) days of the Effective Date, the Parties shall enter into a written Quality Agreement for the product.
10.2 Baxter’s
Representations and Warranties and Covenants. Baxter hereby represents and warrants (or covenants, as applicable) to Kamada
that as of the Effective Date and during the Term:
(a) Baxter is duly
organized, validly existing and in good standing under the laws of Delaware and this Agreement has been duly authorized by all
necessary corporate action.
(b) Baxter has all
necessary corporate power and authority to enter into this Agreement and to perform all of its obligations hereunder.
(c) This Agreement
has been duly authorized, executed and delivered by Baxter and is the legal, valid and binding obligation of Baxter, enforceable
against Baxter in accordance with its terms.
(d) Neither the execution,
delivery and performance by Baxter of this Agreement nor the consummation of the transactions contemplated hereby violate or conflict
with the charter documents of Baxter, any material contract, agreement or instrument to which Baxter is a party or by which it
or its properties are bound, or any judgment, decree, order or award of any court, governmental body or arbitrator by which Baxter
is bound, or any law, rule or regulation applicable to Baxter.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(e) Baxter is not
under any obligations inconsistent with the provisions of this Agreement.
(f) The Product manufactured
and sold under this Agreement, when labeled as directed by Baxter will not at the time of such sale be misbranded within the meaning
of the Act or within the meaning of any applicable law in which the definition of misbranding is substantially the same as that
contained in the Act, as the Act and those laws are constituted and effective at the time of such sale.
(g) To Baxter’s
knowledge, Baxter and all storage and distribution of Product under this Agreement are in material compliance with all applicable
environmental, health, safety and transportation regulations (including, but not limited to, regulations of the U.S. Environmental
Protection Agency, U.S. Occupational Safety and Health Administration, and the U.S. Department of Transportation).
(h) All labels designed
by Baxter for Products shall comply in all material respects with all applicable laws and regulations.
(i) Baxter shall store,
handle and distribute Products in compliance with all applicable laws, guidelines and Specifications.
(j) To the extent
permitted by applicable laws, rules and regulations, Baxter shall use Commercially Reasonable Efforts to ensure that during the
Term of this Agreement and for a period ending [*****] following the expiration labeled shelf life of each unit of Product sold
by Baxter under this Agreement, directly or indirectly through its third party agents and/or customers, Baxter is able to identify
the final disposition of each unit of Product. Upon Kamada’s written request identifying a reasonable need for such data,
Baxter shall use Commercially Reasonable Efforts to obtain such data and to provide all such data to Kamada and/or the applicable
Regulatory Authorities.
ARTICLE 11
REGULATORY MATTERS
11.1 Regulatory
Documentation and Regulatory Licenses.
(a) United States
BLA. Kamada shall be responsible, [*****] for obtaining and maintaining the BLA for all A1PI IV Products
that are manufactured in the Kamada Facility for sale in the United States, its territories and possessions (the “US
BLA”). Kamada shall own such US BLA; provided, however, that following Practice Runs (as defined in the Technology
Sharing Plan), the Clinical/Regulatory Sub-Committee (CRSC) shall discuss, in good faith, the possible regulatory options for the
A1PI IV Products, including transferring the US BLA to Baxter, sharing the US BLA between Kamada and Baxter, and any other possible
regulatory pathways. The CRSC shall also determine the timelines, procedures [*****] by Kamada or Baxter
to effect such regulatory options chosen by the CRSC.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(b) United States
BLA Supplement. Baxter shall be responsible, [*****] for preparing and maintaining the BLA Supplement
for all A1PI IV Product that is manufactured in a Baxter Facility, for sale and distribution in the United States, its territories
and possessions (the “US BLA Supplement”). Kamada shall reasonably cooperate, [*****],
with Baxter in Baxter’s efforts to prepare and/or maintain the US BLA Supplement. In connection therewith, Kamada shall provide
Baxter with copies of such Regulatory Documentation, Regulatory Approvals and other information that may be necessary and/or useful
in Baxter’s efforts pursuant to this Section 11.1(b) to the extent that such information is in Kamada’s possession
or is reasonably accessible by Kamada. Kamada shall be responsible, as BLA holder, for reviewing, filing and holding the BLA Supplement.
During the Term of this Agreement, Kamada shall also timely provide Baxter with copies of updated or amended Regulatory Documentation,
Regulatory Approvals and related information as they are submitted to the respective Regulatory Authorities with respect to the
A1PI IV Products.
(c) Other Territories.
Baxter shall have the exclusive right and shall be responsible, [*****], for obtaining and maintaining all
other BLAs for all A1PI IV Product for sale and distribution in any country in the Baxter Territory other than the United States,
its territories and possessions. Baxter shall own all such BLAs; provided that (i) Kamada shall be notified of all submissions
to Regulatory Authorities in such countries if they affect the A1PI IV Products or Kamada’s products and shall receive electronic
copies of such submissions, (ii) if such Regulatory Authorities require additional studies or information, [*****] and (iii) the terms of Section 11.2 below shall apply, mutatis
mutandis, with respect to any communication with any applicable Regulatory Authority.
11.2 Regulatory
Authority Communications.
(a) Generally.
Except as expressly set forth in this Section 11.2 or as otherwise requested in writing, the Non-BLA Party shall not, directly
or indirectly, communicate with the FDA or the Regulatory Authorities of the applicable country regarding any Regulatory Approval
or BLA for the A1PI IV Product in such country.
(b) Oral Communication
Initiated by Regulatory Authority. If the FDA or other Regulatory Authority initiates any unscheduled oral communication with
the BLA Party directly regarding the Non-BLA Party’s products, or which could impact the Non-BLA Party’s products,
BLA Party shall have the right to respond to such communication to the extent reasonably necessary or appropriate under the circumstances;
provided, however, that (i) BLA Party shall use reasonable efforts to limit the communications regarding the Non-BLA Party’s
products that are conducted without the participation of Non-BLA Party; (ii) promptly thereafter, the BLA Party shall provide Non-BLA
Party with written notice thereof in reasonably specific detail describing the communications regarding Non-BLA Party’s products;
and (iii) the BLA Party promptly shall provide Non-BLA Party with copies of all minutes and other materials resulting therefrom.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(c) With respect to
any meetings, telephone conferences, video conferences or other non-written communication with the FDA or other Regulatory Authority
directly regarding Non-BLA Party’s products, or which could impact the Non-BLA Party’s products, not covered under
Sections 11.2(a) or 11.2(b):
(i) BLA Party shall
provide Non-BLA Party with reasonable written notice thereof in reasonably specific detail sufficiently in advance to allow Non-BLA
Party the opportunity to have one representative actively participate therein;
(ii) upon the request
of Non-BLA Party, BLA Party shall provide Non-BLA Party with advance details regarding the subject matter thereof;
(iii) Non-BLA Party
shall have the right to be present at, and to the extent relating to the Non-BLA Party’s products participate in, any such
meetings, telephone conferences, video conferences or other non-written communication; and
(iv) BLA Party promptly
shall provide Non-BLA Party with copies of all minutes and other materials resulting therefrom.
(d) Pricing and
Reimbursement Approvals. Baxter shall be responsible for obtaining, and undertakes to obtain using its Commercially Reasonable
Efforts, and maintaining all regulatory, administrative, and third party payor-related activities relating to pricing and reimbursement
approvals for the A1PI IV Product in the Baxter Territory (and any country therein). For the avoidance of doubt, the foregoing
shall not require Baxter to seek pricing and/or reimbursement approvals other than in connection with the exercise of Baxter’s
rights and obligations under Section 11.1(c). Baxter shall use its Commercially Reasonable Efforts to obtain any such approvals
for the United States promptly after the Execution Date. Baxter shall have the right to consult with Kamada on the planning and
development of all documentation with respect thereto and Kamada shall use Commercially Reasonable Efforts to cooperate with Baxter’s
efforts in this regard. Baxter shall provide to Kamada for review and approval copies of any proposed submission at least [*****]
business days prior to such submission. All such approvals shall be obtained in the name of Baxter. Upon termination, but not expiration
under Section 15.1, of this Agreement, unless Baxter terminates the Agreement pursuant to Section 15.2(a),
15.2(b) or 15.2(c), Baxter shall promptly assign or cause to be assigned to Kamada all rights and data associated
with all regulatory, administrative, and third party payor-related activities relating to pricing and reimbursement approvals that
Baxter or any of its Affiliates owns and/or has developed in a country within the Baxter Territory with respect to such country.
11.3 Remedial
Actions.
(a) Each Party will
notify the other immediately, and promptly confirm such notice in writing, if it obtains information indicating that an A1PI IV
Product may be subject to any recall, corrective action or other regulatory action (other than a corrective and preventive action
(“CAPA”) under the Act,) worldwide, taken either by virtue of applicable federal, state, foreign or other
law or regulation or good business judgment (a “Remedial Action”).
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(b) The Parties will
assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting Remedial
Action; provided that Baxter shall have sole responsibility for collecting information from its customers, including customer complaints.
The BLA Party shall determine whether to commence any Remedial Action with respect to the A1PI IV Product. Each Party will maintain
adequate records to permit the Parties to trace the manufacture of the applicable A1PI IV Product and the distribution and use
of such product. In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced,
or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially
Reasonable Efforts to conduct such Remedial Action. The other Party shall use Commercially Reasonable Efforts to cooperate with
such Party in implementing any such Remedial Action to the extent such cooperation is necessary to effect the Remedial Action.
The BLA Party shall have sole responsibility for handling any CAPAs in a reasonable manner; provided that Baxter shall be responsible
for handling and shall bear all costs and expenses related to field corrections to the extent caused by the acts or omissions of
Baxter. The other Party shall cooperate with the BLA Party to the extent reasonably requested by the BLA Party in handling
any CAPA. Any costs and expenses incurred by either Party in connection with a Remedial Action shall be borne by the Party whose
acts or omissions caused or resulted in the necessity for such Remedial Action, and such Party shall reimburse or credit the other
Party for any such costs or expenses within [*****] of receiving written notice from the other Party that the cost or expense has
been incurred.
11.4 Pharmacovigilance
and Adverse Event Reporting.
(a) Responsibility.
(i) United States.
As long as Kamada is the BLA Party, Kamada shall be responsible, directly or through a third party and at its sole cost and expense,
for undertaking all pharmacovigilance and adverse event reporting activities within the United States relating to the A1PI IV Product.
Notwithstanding the foregoing, if Baxter receives any telephonic or written or other correspondence relating to an adverse event
for an A1PI IV Product in the United States or elsewhere in the Baxter Territory, Baxter shall use Commercially Reasonable Efforts
to obtain the Minimum PV Information and shall promptly forward such Minimum PV Information to Kamada. Kamada shall fulfill all
regulatory requirements relating to the safety of the A1PI IV Product, including, but not limited to, collecting and assessing
adverse events, reporting safety information (individual case safety reports and aggregate reports), literature searches, risk
management activities, if warranted, responding to regulatory inquiries and conducting pharmacovigilance for the A1PI IV Product.
(ii) Other Countries.
With respect to all other countries in the Baxter Territory, Baxter shall be responsible, at its sole cost and expense, for all
pharmacovigilance and adverse event reporting activities for A1PI IV Product in such countries; provided, however, that Kamada
shall reasonably assist Baxter by providing relevant documentation for such A1PI IV Product.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(iii) Upon either
Party determining that an adverse event report will be filed in a country for which it is responsible for filing adverse event
reports, then the Parties will agree upon an overall strategy for dealing with all Regulatory Authorities in, or, if deemed relevant
by a Party, outside of, the Baxter Territory following such filing.
(b) Pharmacovigilance
Agreement. The Parties shall enter into a separate pharmacovigilance agreement. Such pharmacovigilance agreement should be
executed no later than ninety (90) days from the Effective Date and shall thereafter be attached to this Agreement as Exhibit
11.4(b) and shall then be considered as incorporated into this Agreement by reference. The pharmacovigilance system shall be
operational no later than the first sale of an A1PI IV Product in the Baxter Territory by Baxter or its sub-distributors and Affiliates
(as applicable).
(c) Adverse Event
Reporting. The Parties shall report to each other all information necessary to make timely reports as required by any Regulatory
Authority or other authorized authority in the Baxter Territory and Kamada Territory regarding the A1PI IV Product. Further, the
Parties shall use Commercially Reasonable Efforts to, within ninety (90) days following the Effective Date but in any event prior
to the First Commercial Sale, enter into a written agreement regarding adverse event reporting system and procedures acceptable
to the Parties. The system shall be operational no later than the first sale of an A1PI IV Product in the Baxter Territory by Baxter
or its sub-distributors and Affiliates (as applicable).
(d) Notification
of Complaints. Upon any Party receiving or becoming aware of any complaint involving the possible failure of the A1PI IV Product,
in any location in the world, to meet any requirement of applicable law or regulation, and any serious or unexpected side effect,
injury, toxicity or sensitivity reaction or any unexpected incidents associated with the distribution of the A1PI IV Product, whether
or not determined to be attributable to the A1PI IV Product (i) such Party shall notify the other Party about such complaint and
provide initial information about such complaint to the other Party within [*****] and shall provide all information about such
complaint within [*****], (ii) promptly provide to the other Party copies of any complaints, and provide at the time of submission
copies of any submissions to any Regulatory Authority regarding such complaints and (iii) with respect to adverse events, comply
with the provisions of Section 11.4(c) above. Baxter shall have responsibility for investigating such complaint in
the Baxter Territory, with cooperation and assistance from Kamada in the Baxter Territory, and shall immediately inform Kamada
of any information discovered in the course of the investigation that could show that the complaint is justified and that it resulted
from Kamada’s actions or omissions.
(e) Notification
of Threatened Action. Each Party shall immediately notify the other Party of any information it receives regarding any threatened
or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority which
may affect the safety or efficacy claims of the A1PI IV Product or the continued marketing of the A1PI IV Product. Upon receipt
of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking
appropriate action.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
11.5 Audits.
(a) Baxter Access.
Kamada will give Baxter reasonable access to its records and manufacturing facilities to allow Baxter to conduct full compliance
audits relating to Kamada’s role and obligations as the U.S. BLA holder for the A1PI IV Product, at Baxter’s expense,
as reasonably deemed necessary by Baxter, but no more frequently than once in any [*****] period unless any such audits reveal
a material failure to comply with its obligations under this Agreement or failure to comply with any law, rule or regulation related
to the manufacturing, handling, storage or transport of the A1PI IV Product in which case there shall be no limitation of the frequency
of such compliance audits until such material compliance problems have been corrected at which time the frequency shall be restored
to once in any [*****] period. The audit shall be conducted by Baxter personnel and any of its designated third party Representatives
each of whom shall, in connection with their participation in such audit, agree to execute a confidentiality agreement in favor
of Kamada. The audit may include, without limitation, records relating to manufacturing compliance with the specifications, compliance
with quality control and inspection reports procedures, compliance with cGMP, Title 21 Parts 210 and 211 or other applicable regulations.
Such audits will be conducted during Kamada’s normal business hours, after [*****] written notice to Kamada by Baxter, and
at times mutually agreeable to the Parties. Kamada will make its regulatory compliance and quality assurance personnel (and such
personnel of any sub-contractors, if applicable) reasonably available to Baxter in connection with such audits. If Baxter recommends
any corrective actions to Kamada in connection with such audits, Kamada shall take any corrective action reasonably recommended
by Baxter within [*****] of receipt of any corrective action recommendations, if possible, or will inform Baxter in writing of
the reasons why Kamada believes such corrective action is not required or necessary, or cannot be completed within such [*****]
period and if such reasons are not accepted by Baxter, such dispute shall be resolved through the dispute resolution process in
this Agreement. Baxter shall be given access to audit any corrective action.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(b) Kamada Access.
Baxter will give Kamada reasonable access to its records and facilities (and will obtain sufficient rights to give Kamada reasonable
access to the records and facilities of its Permitted Sublicensees and Affiliates), to allow Kamada to conduct full compliance
audits relating to the A1PI IV Product (including with respect to its manufacture, quality systems, complaint handling, maintenance
of adequate documentation, etc.), at Kamada’s expense, as reasonably deemed necessary by Kamada, but no more frequently than
once in any [*****] period unless any such audits reveals a material failure to comply with this Agreement or failure by Baxter
(or its sub-distributors and Affiliates, if applicable) to comply with any applicable law relating to its obligations under this
Agreement with respect to the A1PI IV Product in which case there shall be no limitation of the frequency of such compliance audits
with respect to the entity for which the material failure was identified, until such material failures have been corrected at which
time the frequency shall be restored to once in any [*****] period. The audit shall be conducted by Kamada personnel and any of
its designated third party Representatives each of whom shall, in connection with their participation in such audit, agree to execute
a confidentiality agreement in favor of Baxter. In furtherance of this right, Baxter agrees that it shall specifically obtain from
any and all third-party or Affiliate distributors of the A1PI IV Product a right of Kamada to conduct audits of such party’s
records and facilities as set forth herein. The audit may include, without limitation, records relating to compliance with quality
control, manufacturing, and inspection reports procedures, compliance with cGMP, Title 21 Parts 210 and 211 or other applicable
regulations. Such audits will be conducted during Baxter’s normal business hours, after [*****] prior written notice to Baxter
by Kamada, and at times mutually agreeable to the Parties. Baxter will make its regulatory compliance and quality assurance personnel
(and such personnel of any sub-distributors, if applicable) reasonably available to Kamada in connection with such audits. If Kamada
recommends any corrective actions to Baxter in connection with such audits, Baxter shall take any corrective action reasonably
recommended by Kamada within [*****] of receipt of any corrective action recommendations, if related to the BLA or BLA Supplement,
or, if such corrective action is not related to the BLA or BLA Supplement (i) will take such corrective action within [*****] of
receipt of any corrective action recommendations, if possible, or (ii) will inform Kamada in writing of the reasons why Baxter
believes such corrective action is not required or necessary, or cannot be completed within such [*****] period and if such reasons
are not accepted by Kamada, such dispute shall be resolved through the dispute resolution process in this Agreement. Kamada shall
be given access to audit any corrective action. In the event that Baxter is not manufacturing or distributing the A1PI IV Product
and is using third parties to manufacture or distribute the A1PI IV Product, Baxter shall obtain all rights necessary from such
third parties to enable Kamada to exercise all of its rights under this Agreement at such third party manufactures’ facilities.
11.6 Regulatory
Inspections. Each Party will promptly notify the other Party and provide copies of any notice of observations or warnings,
requests for Remedial Action, CAPAs or other adverse findings issued by the FDA, ISO or other federal, state, or local regulatory
agency following an inspection of its facilities at which the A1PI IV Product for use or sale within the Baxter Territory is manufactured,
which relates to the manufacture, assembly, or packaging of the A1PI IV Product, and shall further provide the other Party with
information about the progress and outcome of any actions taken in response to any such notices, warnings, requests or findings.
Kamada shall, at its discretion, have the right to attend any Baxter meetings with the FDA, ISO or any other federal, state or
local regulatory agency that relate to the A1PI IV Product in the Baxter Territory.
ARTICLE
12
INTELLECTUAL PROPERTY
12.1 Ownership
of Intellectual Property. Kamada will retain all ownership and control of the Kamada Intellectual Property, and will maintain
all rights in the Kamada Intellectual Property that are or may be useful for the marketing of the Product. Kamada agrees, during
the Term, to maintain and prosecute within the Baxter Territory all such patents, trade secrets, know-how and proprietary material
related to the Product within the Kamada Intellectual Property.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
ARTICLE
13
CONFIDENTIAL INFORMATION
13.1 Confidentiality.
Each Party acknowledges that, in the course of performing its duties and obligations under this Agreement, certain information
that is confidential or proprietary to such Party including the Kamada Intellectual Property (“Confidential Information”)
will be furnished by the other Party or such other Party’s Representatives. Each Party agrees that any Confidential Information
furnished by the other Party or such other Party’s Representatives will not be used by it or its Representatives except in
connection with, and for the purposes of, the manufacturing, promotion, marketing, distribution and sale of Product and for any
other purpose permitted under this Agreement and, except as provided herein, will not be disclosed by it or its Representatives
without the prior written consent of the other Party. Notwithstanding the foregoing, Confidential Information furnished by a Party
may be disclosed by a receiving Party to such receiving Party’s professional advisors or such receiving Party’s bona
fide potential purchasers, acquirers, investors, bankers and lenders, and the professional advisors of the foregoing; provided
that such persons need to know the disclosed information and agree to be bound by the receiving Party’s obligation of confidentiality
with respect to such information. The Parties further agree that all Confidential Information disclosed in written, electronic
or other tangible form (such as a physical prototype, physical sample, photograph or video tape) shall be clearly marked “CONFIDENTIAL”
(or sent in a communication clearly marked “CONFIDENTIAL”) or, if furnished in oral form or by visual observation,
shall be stated to be confidential by the Party disclosing such information at the time of such disclosure and reduced to a writing
by the Party disclosing such information which is furnished to the other Party or such other Party’s Representatives within
[*****] after such disclosure.
13.2 Exceptions.
The confidentiality obligations of each Party under Section 13.1 do not extend to any Confidential Information furnished
by the other Party or such other Party’s Representatives that (a) is or becomes generally available to the public other than
as a result of a disclosure by the recipient Party or its Representatives, (b) is or becomes generally available to the public
as a result of a disclosure specifically permitted under Section 13.3, (c) was available to the recipient Party or its Representatives
on a non-confidential basis prior to its disclosure thereto by the other Party or such other Party’s Representatives as can
be proved by documentary evidence, (d) can be demonstrated by documentary evidence by the recipient Party that it was independently
developed by the recipient Party without reference to any Confidential Information of the other Party, or (e) becomes available
to such Party or its Representatives on a non-confidential basis from a source other than the other Party or such other Party’s
Representatives as can be proved by documentary evidence; provided, however, that such source is not bound by a confidentiality
agreement with the other Party or such other Party’s Representatives.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
13.3 Legally
Required Disclosures. If the Party receiving any Confidential Information or any of its Representatives (the “Receiving
Party”) is required by law, rule or regulation or by order of a court of law, administrative agency, or other governmental
body (including the United States Securities and Exchange Commission or the Israeli Securities Authority) to disclose any of the
Confidential Information, the Receiving Party will (a) promptly provide the other Party (the “Disclosing Party”)
with reasonable advance written notice if at all possible to enable the Disclosing Party the opportunity to seek a protective order
or to otherwise prevent or limit such legally required disclosure, (b) use Commercially Reasonable Efforts to cooperate with the
Disclosing Party to obtain such protection, and (c) disclose only the legally required portion of the Confidential Information.
Any such legally required disclosure will not relieve the Receiving Party from its obligations under this Agreement to otherwise
limit the disclosure and use of such information as Confidential Information.
13.4 Terms
of Agreement. The terms of this Agreement, and the transactions contemplated hereby shall be deemed to be Confidential Information
subject to the provisions of Section 13.1.
13.5 Compelled
Disclosure. In the event that either Party or its Representatives are requested or become legally compelled (by oral questions,
interrogatories, requests for information or document subpoena, civil investigative demand or similar process) to disclose any
Confidential Information furnished by the other Party or such other Party’s Representatives or the fact that such Confidential
Information has been made available to it, such Party agrees that it or its Representatives, as the case may be, will provide the
other Party with prompt written notice of such request(s) so that the other Party may seek a protective order or other appropriate
remedy and/or waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy will
not be obtained, or that the other Party waives compliance with the provisions of this Agreement, such Party agrees that it will
furnish only that portion of such Confidential Information that is legally compelled and will exercise Commercially Reasonable
Efforts to obtain reliable assurance that confidential treatment will be accorded to that portion of such Confidential Information
and other information being disclosed.
13.6 Return
of Confidential Information. Upon termination of this Agreement and upon the request of the Disclosing Party, the Receiving
Party will return to the Disclosing Party all Confidential Information (including copies) provided by the Disclosing Party under
this Agreement, and will destroy all summaries, extracts and the like prepared by the Receiving Party that incorporate the Disclosing
Party’s Confidential Information; provided, however, that the Receiving Party may retain one complete copy of the Confidential
Information, for the purpose of determining its obligations under this Agreement, such copy to be retained by the Legal Department
of the recipient.
13.7 Restriction
on Trading in Securities of Kamada. Baxter acknowledges that information provided to it or to be provided to it under this
Agreement includes confidential and non-public information that may be considered “inside information” under Israeli
securities law. Baxter shall comply with the provisions of Israeli securities laws regarding the use of any such “inside
information.”
13.8 Survival.
The obligations of the Parties under this ARTICLE 13 shall survive for [*****] after the termination or expiration of this
Agreement, except for trade secrets regarding which the confidentiality obligations of the Parties under this Article 10
shall survive indefinitely and information which has been identified as Know-How by a Party and entered into the Know-How Registry
(as such terms are defined in the License Agreement), in which case, the obligations shall survive until the identified Know-How
becomes public information not due to a breach of this Agreement by a Party bound by confidentiality obligations in regard to such
Know-How.
ARTICLE
14
INDEMNIFICATION; INSURANCE REQUIREMENTS; PATENT INFRINGEMENT
14.1 Kamada
Indemnity. Kamada agrees to indemnify, defend and hold Baxter and its Affiliated Parties (collectively, the “Baxter
Indemnified Parties”) harmless from and against all losses, liabilities, damages, costs and expenses (including reasonable
attorney’s fees and costs of investigation and litigation regardless of outcome) resulting from all claims, demands, actions
and other proceedings by or on behalf of any Third Party (including any governmental authority) (collectively, “Claims”)
to the extent arising from:
(a) any material breach
by Kamada of any of its representations, warranties, covenants or material obligations under this Agreement;
(b) the negligence,
gross negligence, recklessness or willful misconduct of Kamada, its Affiliates or agents in the performance of Kamada’s obligations
hereunder;
(c) the failure of
Kamada, its Affiliates or agents to comply with applicable laws, rules or regulations in the manufacture of the Product.
(d) the [*****] Product
to [*****] at the time of delivery to Baxter under this Agreement;
(e) [*****]
(f) [*****]
provided that Kamada shall not be obligated
pursuant to this Section 14.1 to the extent Baxter is required to indemnify Kamada under Section 14.2 hereof.
14.2 Baxter
Indemnity. Baxter agrees to indemnify, defend and hold Kamada (and the Affiliated Parties of any of the foregoing) (collectively,
the “Kamada Indemnified Parties”) harmless from and against all losses, liabilities, damages, costs and
expenses (including reasonable attorney’s fees and costs of investigation and litigation regardless of outcome) resulting
from all Claims to the extent arising from:
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(a) any material breach
by Baxter of any of its representations, warranties, covenants or material obligations under this Agreement;
(b) the negligence,
gross negligence, recklessness or willful misconduct of Baxter, its Affiliates or agents in the performance of Baxter’s obligations
hereunder;
(c) the failure of
Baxter, its Affiliates or agents to comply with applicable laws, rules or regulations in the conduct of the Clinical Trials or
the testing, storage, handling, transportation, disposal, marketing, labeling (to the extent created by Baxter), use, promotion,
commercialization (including any recalls, field corrections or market withdrawals to the extent such result primarily from the
actions or omissions of Baxter), sale or other distribution of the Product;
(d) any [*****] by [*****], except to the
extent such claim is solely related to [*****], or [*****];
provided that Baxter shall not be obligated
pursuant to this Section 14.2 to the extent Kamada is required to indemnify Baxter under Section 14.1 hereof.
14.3 Claims
for Indemnification. Whenever any indemnification claim arises under this Agreement, the Party seeking indemnification (the
“Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”)
of the claim and, when known, the facts constituting the basis of such claim; provided, however, that failure to give such notice
shall not relieve the Indemnifying Party of its obligation hereunder unless and to the extent that such failure substantially prejudices
the Indemnifying Party.
14.4 Third-Party
Claims. In the event of a third party claim giving rise to indemnification hereunder, the Indemnifying Party may, upon prior
written notice to the Indemnified Party, assume the defense of such claim with counsel reasonably satisfactory to the Indemnified
Party, and shall thereafter be liable for all expenses incurred in connection with such defense, including attorneys’ fees
and expenses; provided, however, that if the Indemnifying Party assumes the defense of any such claim, the Indemnified Party may
participate in such defense at its own expense and with counsel of its choice; provided further, however, that if there are one
or more legal defenses available to the Indemnified Party that conflict with those available to the Indemnifying Party or there
exists any other conflict of interest, the Indemnifying Party shall have the right to assume the defense of such claim but the
Indemnified Party shall have the right to employ separate counsel at the expense of the Indemnifying Party and to participate in
the defense thereof. If the Indemnifying Party elects to control the defense of such claim, it shall do so diligently and shall
have the right to settle any claim for monetary damages, provided such settlement includes a complete and absolute release of the
Indemnified Party and shall not admit any fault or liability on the part of the Indemnified Party. Notwithstanding anything to
the contrary, the Indemnifying Party may not settle any claims for fines, penalties or the like or in any way adverse to the Indemnified
Party without the prior written consent of the Indemnified Party, which shall not unreasonably be withheld, conditioned or delayed.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
14.5 Insurance
Requirements. Each Party will, at its own cost and expense, obtain and maintain in full force and effect, during the Term,
General Liability insurance including Completed Operations, and Product Liability, including Standard US’ Form Contractual
Liability, with limits of liability of not less than [*****] dollars [*****] per event and in aggregate per annum, and naming the
other Party as an additional insured. Any independent insurance carriers must be rated at least A by A.M. Best Company. If the
insurance policy is written on a claims-made basis, then the coverage must be kept in place for at least [*****] years after the
termination of this Agreement. Any and all policy deductibles shall be assumed by the Party obtaining such insurance policy. Policies
held by a Party shall be considered primary and bear no relationship to any policies held by the other Party. Each Party will furnish
the other Party with a certificate of insurance within thirty (30) days of the Effective Date of this Agreement evidencing that
such insurance is in effect and that a minimum of thirty (30) days notice must be given to the other Party prior to any cancellation
or material changes to the policy. Baxter has the right to self-insure.
14.6 LIMITATION
ON LIABILITY. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY INCLUDING THE INDEMNIFICATION PROVISIONS UNDER THIS
ARTICLE 14, EXCEPT FOR DAMAGES ARISING FROM A PARTY’S WILLFUL INFRINGEMENT OF THE OTHER PARTY’S INTELLECTUAL
PROPERTY RIGHTS, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY, FOR ANY LOST PROFITS OR ANY INDIRECT, SPECIAL, CONSEQUENTIAL,
PUNITIVE, EXEMPLARY, COLLATERAL OR INCIDENTAL DAMAGES, HOWEVER CAUSED AND BASED ON ANY THEORY OF LIABILITY, ARISING OUT OF THIS
AGREEMENT (INCLUDING LOSS OF USE, DATA, OR BUSINESS), AND WHETHER OR NOT THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH DAMAGES. THIS LIMITATION SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED FOR HEREIN.
THE PARTIES AGREE, HOWEVER, NONE OF THE FOREGOING LIMITATIONS OF THIS SECTION 14.6 APPLY TO ANY AMOUNTS PAID OR PAYABLE
DUE TO ANY THIRD-PARTY RELATED CLAIM, DEMAND, PROCEEDING, SUIT OR ACTION FOR WHICH A PARTY IS OBLIGATED TO INDEMNIFY THE OTHER
PARTY PURSUANT TO SECTION 14.1 OR 14.2, AND ANY SUCH AMOUNTS WILL BE CONSIDERED COMPENSATORY OR DIRECT DAMAGES AND
NOT INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY, COLLATERAL OR INCIDENTAL DAMAGES.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
14.7 Third-Party
Infringement; Failure of Kamada to Enforce Patents.
(a) Each Party shall
promptly notify the other Party in writing of any infringement or violation by any third party of any Kamada Intellectual Property
rights related to the Product of which it becomes aware. In the case of any infringement or violation by any third party in the
Baxter Territory of any Kamada Intellectual Property rights related to the Product, Kamada shall have the right but not the obligation,
at its sole expense, to exercise its rights (including, without limitation, common law and statutory rights) to cause such third
party to cease such infringement and to otherwise enforce such rights. If Kamada determines that Baxter is an indispensable party
to the action, Kamada shall provide written notice to Baxter and Baxter hereby consents to participate in such action. In such
event, Baxter shall have the right to be represented in such action using counsel of its own choice, at its own expense. Notwithstanding
the foregoing, Kamada agrees that it shall not enter into any settlement, consent, order, consent judgment or other voluntary final
disposition of any action it brings under this Section 14.7 relating to the Field and the Baxter Territory without the prior
written consent of Baxter (which consent shall not be unreasonably withheld, conditioned or delayed).
(b) If Kamada (i)
fails to bring an action for infringement within the Field and within the Baxter Territory by a Third Party of a Patent within
the scope of the Kamada Intellectual Property Rights within a period of [*****] after providing written notice to or receiving
written notice from Baxter of the possibility of pursuing such an action, including the evidence supporting such possible action;
(ii) notifies Baxter in writing prior to the expiration of such [*****] period that Kamada declines to bring an action for infringement
within the Field; or, (iii) notifies Baxter in writing that it will not defend a declaratory judgment action brought by a Third
Party alleging the invalidity, unenforceability or non-infringement of any Kamada patent(s) within the Field and the Baxter Territory;
then, Baxter shall have the right, but not the obligation, to bring and control any such action using counsel of its own choice,
at its own expense on no less than [*****] prior written notice (the “Enforcement Notice”) to Kamada
(the “Enforcement Notice Period”).
(c) If Baxter determines
that Kamada is an indispensable party to the action, Baxter shall provide written notice to Kamada and Kamada shall consent to
participate in such action. To the extent that Kamada participates in such action and Kamada consents to be represented by counsel
of Baxter’s choosing, Baxter shall pay Kamada’s reasonable expenses resulting from such action. In the event that Kamada
participates in such an action, but does not consent to representation by counsel selected by Baxter, Kamada shall have the right
to be represented in such action using counsel of its own choice at its own expense. Baxter shall have no right to bring an action
for infringement by a Third Party outside the Field or outside the Baxter Territory of any patent within the scope of the Kamada
Intellectual Property rights.
(d) Notwithstanding
the foregoing, Baxter agrees that it shall not enter into any settlement, consent, order, consent judgment or other voluntary final
disposition of any action it brings under this Section 14.7(d) without the prior written consent of Kamada (which consent
shall not be unreasonably withheld, conditioned or delayed).
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
14.8 Infringement
Defense. In the event either Party receives notice of any claim that the manufacture, use or sale of the Product infringes
the rights of a third party, it shall give prompt notice to the other Party and shall discuss in good faith alternative strategies
for addressing the matter and cooperate with each other to terminate such infringement without litigation. After such discussion,
Kamada shall have the right and obligation, at its sole cost and expense, to defend against such claim. Baxter shall provide, at
Kamada’s sole expense, such assistance and cooperation to Kamada as may be reasonably necessary to defend any such action,
and Kamada shall have the right to settle such action for monetary damages, provided such settlement includes a complete and absolute
release of Baxter. Notwithstanding anything to the contrary, Kamada may not settle any claims for fines, penalties or the like
or in any way adverse to Baxter without the prior written consent of Baxter, which shall not unreasonably be withheld or delayed.
14.9 Cooperation
as to Indemnified Liability. Each Party hereto shall reasonably cooperate with other Party with respect to access to witnesses,
books, records, or other documentation within such Party’s control, if deemed reasonably necessary or appropriate by any
Party in the defense of any claim, which may give rise to indemnification hereunder.
ARTICLE
15
TERM AND TERMINATION
15.1 Term.
This Agreement shall take effect as of the Effective Date and shall continue in full force and effect, subject to Section 15.2
until thirtieth (30th) anniversary of the Effective Date unless otherwise terminated pursuant to Section 15.2
below (the “Term”).
15.2 Termination.
Notwithstanding anything to the contrary contained in this Agreement:
(a) Either Party may
terminate this Agreement, in whole or solely with respect to one or more countries in the Baxter Territory, by giving notice in
writing to the other Party if the other Party is in material breach of this Agreement and shall have failed to cure such breach
within (i) [*****] for a monetary breach or (ii) [*****] days for a non-monetary breach after receipt of a written notice from
the non-breaching Party specifying the breach in detail from the non-breaching Party, unless such non-monetary breach cannot be
cured within such [*****], in which case the breaching Party shall have undertaken a good faith effort to cure such breach within
such [*****] period and diligently prosecuted such cure to prompt completion.
(b) Either Party may
terminate this Agreement, in whole or solely with respect to one or more countries in the Baxter Territory, by giving notice in
writing to the other Party in the event of the granting of a winding-up order in respect of the other Party, or upon an order being
granted against the other Party for the appointment of a receiver over all or substantially all of such other Party’s assets,
or if such other Party passes a resolution for its voluntary winding-up, or if a temporary or permanent liquidator or receiver
over all or substantially all of such other Party’s assets is appointed in respect of such other Party, or if a temporary
or permanent attachment order is granted on all of such other Party’s assets, or a substantial portion thereof and is not
cancelled within [*****], or if such other Party shall seek protection under any laws or regulations, the effect of which is to
suspend or impair the rights of any or all of its creditors, or to impose a moratorium on such creditors, or if anything analogous
to any of the foregoing in this Section 15.2(b) under the laws of any jurisdiction occurs in respect of such other Party;
provided that in the case that any such order or act is initiated by any Third Party, the right of termination shall apply only
if such order or act as aforesaid is not cancelled within [*****] of the grant of such order or the performance of such act.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(c) Baxter
may terminate this Agreement, in whole or solely with respect to one or more countries in the Baxter Territory, upon
[*****] days written notice to the Kamada in the event that:
(i) [*****]
have passed since a court or other legal body of competent jurisdiction determines in a final, non-appealable judgment or binding
ruling that the continued sale and/or use the Product materially infringes a third party’s Intellectual Property rights;
(ii) the Regulatory
Approval in one or more countries has been withdrawn or the application for Regulatory Approval in such country or countries has
been rejected and such decision has not been reversed within [*****] days of its issuance, in each case by the applicable Regulatory
Authority, and in each case provided that such withdrawal or rejection was not primarily caused by the breach by Baxter or any
of its Affiliates of its obligations hereunder; provided that Baxter’s termination right under this Section 15.2(c)(ii)
shall be limited to the affected geography.
(d) Kamada may terminate
this Agreement, in whole or solely with respect to one or more countries in the Baxter Territory, upon
[*****] written notice to Baxter in the event that:
(i) if the Regulatory
Approval in one or more countries has been withdrawn or the application for Regulatory Approval in such country or countries has
been rejected and such decision has not been reversed within [*****] of its issuance, in each case by the applicable Regulatory
Authority, if such withdrawal or rejection was not caused primarily by the breach by Baxter or any of its Affiliates of its obligations
hereunder and provided, further, that Kamada’s termination right under this Section 15.2(d)(i) shall be limited to
the affected geography.
(ii) Baxter fails
to purchase at least [*****] 50 mL vials of Product over any period of [*****] consecutive months [*****] and during the Term of
this Agreement.
(e) Kamada may terminate
this Agreement, in whole or solely with respect to one or more countries in the Baxter Territory, upon written notice to Baxter
(effective immediately), if Baxter infringes Kamada’s intellectual property, including any use of the Kamada Intellectual
Property outside of the Field.
15.3 Rights
and Obligations on Termination. Upon any termination or expiration of this Agreement with respect to all countries within the
Baxter Territory, (a) each Party shall promptly deliver to the other Party or destroy all Confidential Information of the other
Party, including materials, samples and documents of the other Party subject to either Party retaining a copy of the other Party’s
Confidential Information solely for any purpose contemplated by this Agreement or as require by law and (b) Baxter shall cease
marketing, promoting or otherwise using the Product immediately after the resale of any inventory as permitted in Section15.4(d).
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
15.4 Effect
of Termination. Except as otherwise provided in this Agreement:
(a) Termination or
expiration of this Agreement shall not release either Party from the obligation to make payment of all amounts due and payable
as of the applicable expiration or termination date. For the avoidance of doubt, except in the event that Kamada terminates this
Agreement in accordance with Sections 15.2(a), 15.2(b) and 15.2(d). Baxter shall have no continuing obligations
with respect to Minimum Purchase Levels.
(b) The terminating
Party shall have the right, at its option, to cancel any or all purchase orders that provide for delivery after the effective date
of termination.
(c) If Kamada terminates
this Agreement pursuant to Sections 15.2(a), 15.2(b) and 15.2(d) Baxter shall reimburse Kamada at its actual cost therefor
for any in-process materials and Product specific labels and inserts not otherwise useable or saleable by Kamada after exercise,
by Kamada, of Commercially Reasonable Efforts to mitigate any such loss.
(d) At Kamada’s
election (i) Baxter shall be permitted to resell any inventory of the Product on hand or en route or which has been ordered from
Kamada at the time of termination and the license granted pursuant to Section 3.1 shall continue for [*****] days or until
all such units of Product have been sold, if earlier, or (ii) Kamada shall be permitted to purchase Baxter’s inventory on
hand at the Transfer Price paid by Baxter plus all shipping and other costs reasonably incurred by Baxter in handling and storing
such Product.
(e) Baxter’s
and Kamada’s respective indemnification obligations and their other respective obligations pursuant to Sections 5.4
and 5.7, and ARTICLE 9, Section 11.3, Section 11.4, ARTICLE 12, ARTICLE 13, ARTICLE
14 (provided however, that the obligations under Section 14.5 shall be for the time period set forth therin), and
ARTICLE 18 shall survive termination of this Agreement.
(f) Except as specifically
set forth in this ARTICLE 15, or any other provision in this Agreement upon termination of this Agreement for any reason,
neither Party shall have any further obligations pursuant to this Agreement.
ARTICLE
16
NOTICES
16.1 Notices.
All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be given (and shall be
deemed to have been duly given upon receipt) by delivery in person, by cable, telegram, facsimile or telex, or by registered or
certified mail (postage prepaid, return receipt requested), to the other Party at the following address (or at such other address
for which such Party gives notice hereunder):
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
| If to Baxter: |
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015
Attention: President BioScience
Telephone: (847) 948-3400
Facsimile: (847) 948-3400 |
| |
|
| |
with a copy to: |
| |
|
| |
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015
Attention: General Counsel
Telephone: (847) 948-3225
Facsimile: (847) 948-2450 |
| |
|
| If to Kamada: |
Kamada Ltd.
Science Park
Kiryat Weizmann
7 Sapir St. P.O Box 4081
Ness Ziona 74140, Israel
Attention: Chief Executive Officer
Telephone: +972 8 9406472
Facsimile: +972 8 9406473 |
ARTICLE
17
EXCLUSIVITY; NO-SHOP
17.1 Exclusivity
Regarding Intravenous and Inhaled Product.
(a) During the No-Shop
Period (as defined in Section 17.1(c) below), Kamada agrees to suspend any discussions or negotiations presently being conducted,
and agrees not to undertake, solicit or otherwise encourage any new discussions or negotiations, with any third party with respect
to: (i) any [*****] or (ii) any [*****] related to either (X) the [*****] and (Y) the [*****], with respect to [*****] in which
[*****] (each, a [*****] and, together with any [*****], a “Restricted Transaction”).
(b) Further, without
the prior written consent of Baxter, during the No-Shop Period, Kamada will not: (i) [*****], any [*****] with respect to, or the
making of, any Restricted Transaction or (ii) [*****] any [*****], or [*****] with any [*****] relating to any restricted Transaction.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
(c) Notwithstanding
the foregoing, Kamada shall have the right to continue pursuing its research and development goals concerning [*****] and [*****]
at its sole discretion during the No-Shop Period. Kamada’s obligations under this Section 17.1 commence on the Effective
Date and expire on December 31, 2010; provided that, if Baxter has completed its due diligence process and the Parties are still
negotiating at such date the terms of a binding agreement for a Restricted Transaction, the expiration date shall be March 31,
2011 (the “No-Shop Period”).
(d) Until the expiration
of the No-Shop Period, Baxter and Kamada shall negotiate in good faith the terms of a collaboration with respect to [*****] and
[*****] in [*****] in which [*****], with the goal being the execution of one or more definitive distribution agreement(s) for
[*****] and/or [*****] in such [*****] by December 31, 2010. For the avoidance of doubt, any failure of the Parties to reach any
or all of such agreements shall not give rise to a right to terminate this Agreement. In connection therewith, Baxter shall be
permitted to conduct further detailed due diligence as appropriate in view of the progress in the negotiations, and as deemed relevant
to the proposed transaction for the [*****] and/or [*****] in such [*****] in Baxter’s and Kamada’s discretion, including,
but not limited to: (i) pre-clinical and clinical trials, (ii) process development and manufacturing performance and (iii) intellectual
property such due diligence process to end no later than November 15, 2010. Kamada shall use its Best Efforts to facilitate such
due diligence review by Baxter and provide Baxter with full access to Kamada’s books, records, facilities and employees.
ARTICLE
18
MISCELLANEOUS
18.1 Relationship
of Parties. The relationship of the Parties established by this Agreement is solely that of independent contractors, and nothing
shall be deemed to create or imply any employer/employee, principal/agent, partner/partner or co-venturer relationship, or that
the Parties are participants in a common undertaking. Neither Party shall have the right to direct or control the activities of
the other Party or incur or assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf
of the other Party or bind such other Party to any obligation for any purpose whatsoever.
18.2 Entire
Agreement. This Agreement, including the exhibits and schedules attached hereto and incorporated as an integral part of this
Agreement, and the Related Agreements constitute the entire agreement of the Parties with respect to the subject matter hereof,
and supersede all previous proposals, oral or written, and all negotiations, conversations or discussions heretofore had between
the Parties related to this Agreement.
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
18.3 No
Waiver; Amendment. No waiver of any term or condition of this Agreement shall be valid or binding on any Party unless agreed
to 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 waiver of such provisions, nor in any way affect the ability of either Party to enforce
each and every such provision thereafter. This Agreement may not be amended or modified except by the written agreement of the
Parties. All purchase orders are subject to the terms and conditions of this Agreement, and any attempt by such purchase order
to alter or modify the terms and conditions of this Agreement shall be void.
18.4 Assignment.
(a) Except
as provided in below, neither Party may assign or otherwise transfer its rights and obligations under this Agreement without the
prior written consent of the other Party. Any attempted assignment or transfer in violation of this provision shall be null and
void. Unless prohibited by law, either Party may assign or otherwise transfer (whether by operation of law, change of control or
otherwise) its rights and obligations under this Agreement, without the prior written consent of the other Party, (A) to an Affiliate,
provided that the assigning Party remains responsible for the performance of this Agreement by such Affiliate or (B) in connection
with a sale of all or substantially all of the assets or equity of the business entity, division or unit, as applicable, that,
in the case of Kamada, manufactures or sells, or, in the case of Baxter, markets, distributes or sells the Product, provided that
in the case of such an asset sale such assignee agrees to be bound by the terms of this Agreement. Prior to or promptly after any
assignment not requiring consent of the other Party, the assigning Party shall give the other Party notice of the assignment. Notwithstanding
the foregoing, if Kamada proposes to assign or otherwise transfer this Agreement or any of its rights or obligations under this
Agreement to a Competitor, Kamada and Baxter agree to work together in good faith prior such assignment to amend this Agreement
to limit, to Baxter’s reasonable satisfaction, Baxter’s obligation to disclose to such Competitor any Confidential
Information or other sensitive or proprietary information.
(b) All
terms and conditions of this Agreement shall be binding on and inure to the benefit of the successors and permitted assigns of
the Parties.
18.5 Force
Majeure. Except for each Party’s confidentiality and indemnity obligations, any delay in the performance of any of the
duties or obligations of either Party hereto (except the payment of money), to the extent caused by an event outside the affected
Party’s reasonable control, shall not be considered a breach of this Agreement, and unless provided to the contrary herein,
the time required for performance shall be extended for a period equal to the period of such delay. Such events (hereinafter referred
to as “Force Majeure” events) shall include without limitation, acts of God; acts of public enemies;
war, terrorism, insurrections; riots; injunctions; embargoes; labor disputes affecting third parties providing services to a Party
under this Agreement (including strikes, lockouts, job actions, or boycotts); fires; explosions; floods; shortages of material
or energy; acts or orders of any government or agency thereof or other unforeseeable causes beyond the reasonable control and without
the fault or negligence of the Party so affected. The Party so affected shall give prompt written notice to the other Party of
such cause and a good faith estimate of the continuing effect of the Force Majeure condition and duration of the affected Party’s
nonperformance, and shall take whatever reasonable steps are appropriate to relieve the effect of such causes as rapidly as possible.
18.6 Governing
Law. The validity, interpretation, and enforcement of this Agreement and all matters arising directly and indirectly from this
Agreement shall be governed by the internal laws of the State of New York, without regard to any conflicts or choice of law rules.
18.7 Dispute
Resolution. Except with respect to claims for equitable relief, which the Parties agree may be pursued in any court of competent
jurisdiction, any dispute, controversy, claim or other matter in question between the Parties arising out of or relating to this
Agreement, including all issues of fact and law, shall be settled by binding arbitration in accordance with the Alternative Dispute
Resolution provisions set forth in Exhibit 18.7.
18.8 Remedies.
The exercise of any remedies hereunder shall be cumulative and in addition to and not in limitation of any other remedies available
to such Party at law or in equity.
18.9 Further
Assurances. Each Party agrees to cooperate fully with the other and execute such instruments, documents and agreements and
take such further actions to carry out the intents and purposes of this Agreement.
18.10 Counterparts;
Facsimile. This Agreement may be executed in more than one counterpart, each of which constitutes an original and all of which
together shall constitute one enforceable agreement. For purposes of this Agreement and any other document required to be delivered
pursuant to this Agreement, facsimiles or electronic reproductions of signatures shall be deemed to be original signatures. In
addition, if any of the Parties sign facsimile copies of this Agreement, such copies shall be deemed originals.
18.11 Construction;
Interpretation. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement. Any article, section, recital, exhibit, schedule and party references are to this
Agreement unless otherwise stated. No Party, nor its counsel, shall be deemed the drafter of this Agreement for purposes of construing
the provisions of this Agreement, and all provisions of this Agreement shall be construed in accordance with their fair meaning,
and not strictly for or against any Party. Except where the context otherwise requires, where used, the singular shall include
the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is
used in the inclusive sense (and/or). The term “includes” and “including” as used herein means including,
but not limited to. Unless otherwise noted, “days” shall refer to calendar days and not business days. Capitalized
terms used but not defined herein shall have the meanings ascribed to them in the License Agreement or, if not defined therein,
the Paste Supply Agreement.
18.12 Press
Releases and Announcements; Use of Names. Neither Party may issue any press release or make any public announcement concerning
the transactions contemplated by this Agreement without the prior consent of the other Party (which consent shall not be unreasonably
withheld, conditioned or delayed). Notwithstanding the foregoing, if a press release or other public announcement with respect
to the subject matter herein is required by applicable law or any listing agreement with a securities exchange or quotation system,
the Party required to make such announcement may do so provided that such Party has provided reasonable notice and a copy of such
announcement to the other Party as promptly as practicable in advance of such announcement and, to the extent practicable, take
the views of the other Party in respect of such announcement into account prior to making such announcement. Notwithstanding the
foregoing, Baxter or Kamada shall not be prevented from mentioning the name of the other Party, or from disclosing any information
if, and to the extent that, such mention or disclosure is to competent authorities for the purposes of obtaining Regulatory Approval
or permission for the exercise of its obligations under the this Agreement. A press release and immediate report regarding this
Agreement to be published by Kamada and approved by the Parties is attached as Exhibit 18.12.
18.13 Severability.
Each Party hereby agrees that it does not intend, by its execution hereof, to violate any public policy, statutory or common laws,
rules, regulations, treaty or decision of any government agency or executive body thereof of any country or community or association
of countries. Should one or more provisions of this Agreement be or become invalid, the Parties hereto shall substitute, by mutual
consent, valid provisions for such invalid provisions which valid provisions in their economic and other effects are sufficiently
similar to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with
such valid provisions. In case such valid provisions cannot be agreed upon, the invalidity of one or several provisions of this
Agreement shall not affect the validity of this Agreement as a whole or the validity of any portions hereof, unless the invalid
provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have
entered into this Agreement without the invalid provisions.
18.14 Non-Solicitation.
Each Party agrees that it shall not, during the Term and for one year afterwards, directly or indirectly, solicit the services,
as employee, consultant or otherwise, any employee of the other Party; provided, however, that nothing in this Section 18.14 shall
prohibit a Party or any Affiliate of such Party from: (a) hiring any employee that has responded to a general advertisement or
solicitation made to the general public or the industry in general or (b) soliciting the services, as employee, consultant or otherwise,
or hiring any such employee after the date that is [*****] after
the date on which such employee leaves the employ of such other Party. In the event of a violation of this non-solicitation obligation,
the violating Party shall pay to the other Party a penalty in the amount of the [*****]
salaries (including bonuses) of the respective employee/personnel; provided, however, that the foregoing shall not prevent the
non-violating party from seeking other equitable relief (including, but not limited to, an injunction) to stop the solicitation
or other violation and such other damages as determined in accordance with the terms of this Agreement. The provisions of this
Section 18.14 shall survive termination of this Agreement.
[Signature Page Follows]
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
[Signature Page to Exclusive Manufacturing,
Supply and Distribution Agreement]
IN WITNESS WHEREOF,
the Parties have caused this Agreement to be executed on the date first above written.
|
BAXTER HEALTHCARE
CORPORATION |
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KAMADA LTD. |
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| By: |
/s/ Joy A. Amundson |
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By: |
/s/ David Tsur |
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| Name: Joy A. Amundson |
|
Name: David Tsur |
|
| Title: CVP, President - Bioscience |
|
Title: Chief Executive Officer |
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| |
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| |
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By: |
/s/ Eyal Leibovitz |
|
| |
|
Name: Eyal Leibovitz |
|
| |
|
Title: Chief Financial Officer |
|
| |
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|
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|
Exhibit 1.88
Specifications
[To be attached.]
This Exhibit 1.88 has been redacted in
its entirety.*
* Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
Exhibit 4.2(h)
Sample Certificate of Analysis
[To be attached.]
This exhibit has been redacted in its
entirety.*
* Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
Exhibit 8.1(a)
Clinical Study Plan
[To be attached.]
Exhibit 8.3
Joint Steering Committee
| 1.1 | Joint Steering Committee; Sub-Committees. |
| a) | Structure. To facilitate communication between the Parties with respect to the License Agreement,
this Agreement and the implementation of and the Technology Sharing Plan during the Term of this Agreement, the Parties shall appoint
a Joint Steering Committee consisting of two (2) representatives nominated by Baxter and two (2) representatives nominated by Kamada.
The JSC shall appoint a chairperson from among its members, which shall initially be a Representative from Kamada, and then rotate
annually between the parties. The chairperson shall be responsible for calling meetings of the JSC and for leading the meetings.
The initial representatives shall be set forth in writing within thirty (30) days after the Effective Date. Each Party may replace
its representatives by providing written notice to the other Party. Employees and other representatives of each Party that are
not members of the Joint Steering Committee may attend meetings of the Joint Steering Committee and any Sub-Committees (as defined
below) as required to further the activities contemplated by this Agreement. |
| b) | Time and Location of Meetings. The Joint Steering Committee (and all Sub-Committees thereof)
shall meet at such times and places, in person or by telephone conferencing, web-conferencing, video conferencing or other electronic
communication, as it shall determine to carry out its responsibilities; provided, however, that the initial meeting of the Joint
Steering Committee shall be held in person at such location as mutually agreed upon by the parties no later than thirty (30) days
after the Effective Date. Thereafter, the JSC shall meet in person at least two (2) times each calendar year and shall hold regular
teleconferences between meetings not less frequently than once each calendar quarter. The location of the in-person meetings shall
alternate between the two companies’ sites. If a representative of a party is unable to attend a meeting, such party may
designate an alternate to attend such meeting in place of the absent representative. |
| c) | Minutes. The JSC and all sub-committees thereof shall designate for each meeting one person
who shall be responsible for drafting and issuing minutes of the meeting reflecting all material items discussed and any agreements
of the JSC, which minutes shall be distributed to all JSC members for review and approval. Such minutes shall provide a description
in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by
the JSC. Minutes of each JSC meeting shall be approved or disapproved, and revised as necessary, within thirty (30) days of each
such meeting. Final minutes of each meeting shall be distributed to the members of the JSC by the chairperson |
| d) | Sub-Committees. Certain sub-committees (each a “Sub-Committee”), including
but not limited to a Manufacturing Sub-Committee, a Clinical/Regulatory Sub-Committee a Pharmacovigilance/Safety Sub-Committee,
a Technology Transfer Sub-Committee and a Marketing and Sales Sub-Committee will be established by the JSC as necessary, with equal
representation from Baxter and Kamada to address specific issues in greater detail (e.g., clinical/regulatory efforts). Unless
otherwise agreed, Baxter and Kamada will have equal membership and voting power on all Sub-Committees. |
| e) | Scope of Authority; Responsibilities. |
| (i) | The Joint Steering Committee shall, subject to the restrictions set forth in this Agreement, have
the authority to make decisions relating to the ongoing management of the relationships between the parties with respect to the
Distribution Agreement and License Agreement and the implementation and modification technology transfer pursuant to the Technology
Sharing Plan. The Joint Steering Committee shall have such other responsibilities as set forth herein and as the Parties may agree
in writing from time to time. |
| (ii) | For the avoidance of doubt, the Joint Steering Committee shall have no authority to: (A) amend
any of the terms of this Agreement (other than the Technology Transfer Plan); (B) waive any rights that either Party may otherwise
have pursuant to this Agreement or otherwise or (C) allocate the ownership of any Intellectual Property rights or the Parties’
rights to apply for Patent(s). Notwithstanding the foregoing, the JSC may make recommendations to the parties for amendment of
this Agreement. |
| f) | Decisions. Except as expressly set forth below with respect to certain of decisions of certain
of the Sub-Committees, the decisions of the Joint Steering Committee must be unanimous with representatives of Baxter having one
collective vote and representatives of Kamada having one collective vote. If a dispute arises regarding matters within the scope
of responsibilities of the Joint Steering Committee, and the Joint Steering Committee fails to reach a unanimous decision on its
resolution within thirty (30) days of when the dispute was first presented to the Joint Steering Committee, then the matter shall
be elevated through each Party’s respective senior management representatives for resolution. If the matter remains unresolved
fifteen (15) days after referral to such senior management representatives, it shall be resolved pursuant to the Alternative Dispute
Resolution procedures as set forth in this Agreement. |
| a) | Generally. At its initial meeting, the JSC shall establish and appoint members to the Sub-Committees
set forth in this Section 1.2. Each such Sub-Committee shall hold its first meeting in person within thirty (30) days of
its formation at such location designated by the JSC. |
| b) | Manufacturing Sub-Committee. The manufacturing sub-committee (the “MSC”)
shall be responsible for, among other things, management of all manufacturing activities related to the Product and the Baxter
Product. The MSC shall not have any responsibility regarding the manufacturing in the Kamada facility. Baxter and Kamada shall
have equal representation and equal voting on the MSC; provided, however, to the extent there is a deadlock Baxter shall have the
deciding vote to the extent not inconsistent with the BLA. |
| c) | Regulatory Sub-Committee. The clinical/regulatory sub-committee (the “RSC”)
shall be responsible for, among other things, management of all regulatory activities related to the A1PI IV Product. Baxter and
Kamada shall have equal representation and equal voting on the RSC; provided, however, to the extent there is a deadlock, the BLA
Party shall have the deciding vote. |
| d) | Clinical Sub-Committee. The clinical/regulatory sub-committee (the “CSC”)
shall be responsible for, among other things, management of all clinical activities related to the A1PI IV Product. Baxter and
Kamada shall have equal representation and equal voting on the CSC; provided, however, to the extent there is a deadlock, Baxter
shall have the deciding vote. |
| e) | Pharmacovigilance/Safety Sub-Committee. The pharmacovigilance/safety sub-committee (the
“PSSC”) which shall have authority for any matters related to adverse events or issues relating to product quality
for the Product and the Baxter Product and shall be an independent safety/quality monitoring sub-team with no representation by
any of the commercial/marketing members from Baxter or Kamada. After the initial meeting required pursuant to this Section 1.2,
the PSSC shall meet as required. Baxter and Kamada shall have equal representation and equal voting on the PSC; provided, however,
to the extent there is a deadlock on a matter the BLA Party shall have the deciding vote. |
| f) | Technology Transfer Sub-Committee. The Technology Transfer sub-committee (the “TTSC”)
shall be responsible for, among other things, management and execution of the Technology Sharing Plan. After the initial meeting
required pursuant to this Section 1.2, the TTSC shall meet as required to address any matters related thereto. Baxter and
Kamada shall have equal representation and equal voting on the TTSC; provided, however, to the extent there is a deadlock on a
matter the matter shall be elevated through the JSC for resolution. |
| g) | Marketing and Sales Subcommittee. The Marketing and Sales sub-committee (the “MSSC”)
shall be responsible for, among other things, marketing and sales of the Product. After the initial meeting required pursuant to
this Section 1.2, the MSSC shall meet as required to address any matters related thereto. Baxter and Kamada shall have equal
representation and equal voting on the MSSC; provided, however, to the extent there is a deadlock on a matter, Baxter shall have
the deciding vote. |
Exhibit 11.4(b)
Pharmacovigilance Agreement
[To be attached.]
Exhibit 18.7
Alternative Dispute Resolution
| (a) | The Parties shall attempt to resolve any and all disputes, claims or controversies arising out
of or relating to this Agreement promptly by negotiation between executives who have authority to settle the controversy. If such
disputes, claims or controversies are not resolved through such negotiation, then they shall be submitted to the International
Institute for Conflict Prevention and Resolution (the “CPR”) for mediation, and if the matter is not resolved through
mediation, for final and binding arbitration pursuant to the arbitration clause set forth below. Either Party may initiate arbitration
with respect to the matters submitted to negotiation by filing a written demand for arbitration at any time following the initial
negotiation session. |
| (b) | To the extent not resolved by mediation, any dispute, claim or controversy arising out of or relating
to this Agreement or the breach, termination, enforcement, interpretation or validity thereof, including the determination of the
scope or applicability of this agreement to arbitrate, shall be determined by arbitration conducted in the English language. The
arbitration shall take place in New York, New York. The arbitration shall be administered by CPR pursuant to its Arbitration Rules
and Procedures. References herein to any arbitration rules or procedures mean such rules or procedures as amended from time to
time, including any successor rules or procedures, and references herein to the CPR include any successor thereto. The arbitration
shall be before three (3) arbitrators. Each Party shall designate one arbitrator in accordance with the “screened”
appointment procedure provided in Rule 5.4 of the CPR Rules. The two Party-appointed arbitrators will select the third, who will
serve as the panel’s chair or president. All three (3) arbitrators shall have experience in the area under dispute. This
arbitration provision, and the arbitration itself, shall be governed by the laws of the State of New York, and the Federal Arbitration
Act, 9 U.S.C. §§ 1-16. |
| (c) | Consistent with the expedited nature of arbitration, each Party will, upon the written request
of the other Party, promptly provide the other with copies of documents on which the producing Party may rely in support of or
in opposition to any claim or defense. At the request of a Party, the arbitrators shall have the discretion to order examination
by deposition of witnesses to the extent the arbitrator deems such additional discovery relevant and appropriate. Depositions shall
be limited to a maximum of five per Party and shall be held within 45 days of the grant of a request. Additional depositions may
be scheduled only with the permission of the arbitrators, and for good cause shown. Each deposition shall be limited to a maximum
of one day’s duration. All objections are reserved for the arbitration hearing except for objections based on privilege and
proprietary or confidential information. The Parties shall not utilize any other discovery mechanisms, including international
processes and U.S. federal statutes, to obtain additional evidence for use in the arbitration. Any dispute regarding discovery,
or the relevance or scope thereof, shall be determined by the arbitrators, which determination shall be conclusive. All discovery
shall be completed within 60 days following the appointment of the arbitrators. All costs and/or fees relating to the retrieval,
review and production of electronic discovery shall be paid by the Party requesting such discovery. |
| (d) | The panel of arbitrators shall have no power to award non-monetary or equitable relief of any sort.
The arbitrators will have no authority to award punitive or other damages not measured by the prevailing Party’s actual damages,
except as may be required by statute. Each Party expressly waives and foregoes any right to consequential, punitive, special, exemplary
or similar damages or lost profits. The arbitrators shall have no power or authority, under the CPR Rules for Non-Administered
Arbitration or otherwise, to relieve the Parties from their agreement hereunder to arbitrate or otherwise to amend or disregard
any provision of this Agreement. Subject to the provisions set forth in subsection (e) below, the award of the arbitrators shall
be final, binding and the sole and exclusive remedy to the Parties. Either Party may seek to confirm and enforce any final award
entered in arbitration, in any court of competent jurisdiction. The cost of the arbitration, including the fees of the arbitrators,
shall be borne by the Party the arbitrator determines has not prevailed in the arbitration. |
| (e) | If an arbitral award does not contain an award of money damages in excess of [*****],
then the arbitral award shall not be appealable and shall only be subject to such challenges as would otherwise be permissible
under the Federal Arbitration Act, 9 U.S.C. §§ 1-16. In the event that the arbitration results in an arbitral award,
which imposes a monetary award in excess of [*****], such award may
be appealed to a tribunal of appellate arbitrators via the CPR Arbitration Appeal Procedure, whose determination shall be final. |
| (f) | Except as may be required by law, neither a Party nor an arbitrator may disclose the existence,
content, or results of any arbitration hereunder without the prior written consent of both Parties. |
[*****] Confidential portions of this document
have been redacted and filed separately with the Securities and Exchange Commission.
Exhibit 18.12
Draft Press Release and Immediate Report
[To be attached.]
