Exhibit 10.1

 

MANUFACTURING SERVICES AGREEMENT

 

This Manufacturing Services Agreement (this “Agreement”) is made and entered
into this 12th day of August 2016 (the “Effective Date”) by and between Propanc
Health Group Corporation, having its office at 555 Riversdale Road, Camberwell,
Victoria, 3124, Australia (“COMPANY”) and Q-Biologicals NV, having its office at
Technologiepark 4, 9052 Zwijnaarde, Belgium, RPR Gent 840.165.203
(“Q-BIOLOGICALS”).

 

Q-BIOLOGICALS and COMPANY being collectively referred to below as the “Parties”
and individually as a “Party.”

 

Whereas, Q-BIOLOGICALS is a contract manufacturing organization with premises at
Technologiepark 4, 9052 Ghent Belgium;

 

Whereas, COMPANY is a research and development organization with premises at
level 2, 555 Riversdale Road, Camberwell, Victoria, 3124, Australia.

 

Whereas, COMPANY desires to engage Q-BIOLOGICALS to provide, and Q-BIOLOGICALS
desires to provide to COMPANY, under the terms and conditions set forth herein,
the Services (as defined in Section 1.1) for the Products (as defined in Section
1.1);

 

NOW, THEREFORE, in consideration of the foregoing, and the mutual covenants
contained herein, COMPANY and Q-BIOLOGICALS, intending to be legally bound,
hereby agree as follows:

 

Article 1
OBJECT OF THE AGREEMENT

 

1.1           COMPANY appoints Q-BIOLOGICALS, who accepts, to perform the cGMP
contract manufacturing services described in Annex 1 hereto (the “Services”)
with respect to the enzymes trypsinogen and chymotrypsinogen. When used in this
Agreement (or in the Quality Assurance Agreement, as defined below), “Products”
shall mean, as the context may require, (i) purified trypsinogen and
chymotrypsinogen (“Drug Substance”), or (ii) the formulated and/or
filled/finished product containing trypsinogen or chymotrypsinogen (“Drug
Product”), or (iii) both the Drug Substance and Drug Product, as further
described in detail in Annex 1.

 

1.2           Q-BIOLOGICALS shall carry out the Services in good faith and with
the standards of care and diligence currently applied in the biopharmaceutical
industry. Q-BIOLOGICALS shall perform the Services in accordance with (i) the
cGMP terms and conditions more amply described in the Quality Assurance
Agreement attached in Annex 2 to this Agreement (the “Quality Assurance
Agreement”), (ii) the applicable laws and regulations of the country where the
Facility (as defined in Section 1.3) is located, any all other laws applicable
to the performance of the Services and Q-BIOLOGICALS’s obligations under this
Agreement or the Quality Assurance Agreement (collectively, “Laws”); (iii)
Q-BIOLOGICALS’s standard operating procedures agreed between the Parties through
the signing of the batch records by Parties’ respective quality persons; and
(iv) the Product specifications set forth in Annex 3 hereto (the
“Specifications”). “cGMP” as used herein shall mean current Good Manufacturing
Practices as defined in the EU Directive 2003/94/EC, as implemented (if any)
into local law, including any and all future amendments thereto.

 

 

 

 

1.3           Q-BIOLOGICALS shall perform the Services at its premises at
Technologiepark 4, Ghent, Belgium (the “Facility”), except for that part of the
Services which shall be performed by Authorized Subcontractors (as defined in
Section 3.3).

 

1.4           Q-BIOLOGICALS shall use commercially reasonable efforts to perform
the Services within the timelines set forth in Annex 1 hereto. Q-BIOLOGICALS
shall inform COMPANY promptly if at any time during the Term (as defined in
Section 8.1) Q-BIOLOGICALS is unable to comply with said timelines. Unless in
the case of negligence or willful misconduct of Q-BIOLOGICALS or any of its
Personnel, Q-BIOLGICALS shall not be liable towards COMPANY for not meeting said
timelines. As used in this Agreement, “Personnel” shall mean, with respect to a
Party, the agents, employees, contractors or subcontractors engaged or appointed
by such Party.

 

1.5           Q-BIOLOGICALS shall obtain and maintain such approvals, permits
and licenses as may be required by any regulatory authority of the jurisdiction
where the Facility is located or any applicable Law, for the Services or the
manufacturing at the Facility of the Products for clinical development.

 

1.6           Q-BIOLOGICALS shall maintain, during the Term and for a period of
five (5) years after the relevant batch release, true, accurate and complete
books, records, reports and accounts in connection with or relative to the
Product and the performance of the Services, as set forth in the Quality
Assurance Agreement.

 

1.7           Q-BIOLOGICALS shall maintain the Facility in good working order
and within cGMPs (e.g., qualification, calibration, maintenance, validation),
including critical systems (e.g., utilities, HVAC, clean steam, compressed
gasses, etc.).

 

1.8           COMPANY’s contact person at Q-BIOLOGICALS shall be Martine
Vandermarliere (the “Project Manager”). Q-BIOLOGICALS shall notify COMPANY
promptly in writing of a change (if any) in Project Manager. The Parties shall
regularly organize face-to-face meetings and/or calls to discuss the progress of
the Services. Each Party will bear its own costs in relation to such meetings
and/or calls.

 

1.9           COMPANY shall have the right to use the Products manufactured
under this Agreement for development purposes, including for clinical trial
purposes. COMPANY shall not have the right to use the Products manufactured
under this Agreement for commercialization relating to human use, unless
explicitly agreed in writing in advance by Q-BIOLOGICALS.

 

1.10         Q-BIOLOGICALS will use commercially reasonable efforts to cooperate
with COMPANY and its successors, licensees or sublicensees with respect to
obtaining all regulatory approvals relating to the Products. Q-BIOLOGICALS will
provide COMPANY with such manufacturing information and quality control
documents as set forth in the Quality Assurance Agreement. Notwithstanding
anything to the contrary in this Section, all CMC information that relates
solely to the Products will be owned exclusively by, and will be the exclusive
proprietary information of COMPANY.

 

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Article 2
INFORMATION AND MATERIALS

 

2.1           COMPANY shall provide Q-BIOLOGICALS with the information and
assistance described in Annex 1 hereto, and such other information and
assistance as the Parties may agree in writing from time to time.

 

2.2           Within two (2) weeks from Q-BIOLOGICALS’s request, COMPANY shall
provide Q-BIOLOGICALS, free of charge and at COMPANY’s transportation risk, with
the materials described in Annex 1 hereto and in the quantities (if any) stated
in that paragraph, which Q-BIOLOGICALS shall use to perform the Services
(hereafter the “Materials”). Q-BIOLOGICALS shall promptly notify COMPANY in
writing of obvious defects in the Materials delivered by COMPANY or on behalf of
COMPANY hereunder discovered by Q-BIOLOGICALS upon receipt of the Materials. As
soon as practicable after receipt of said notice COMPANY shall provide
Q-BIOLOGICALS with replacement Materials at its own cost and Q-BIOLOGICALS shall
promptly return said defective Materials to COMPANY at COMPANY’s expense or, at
Company’s election, destroy them.

 

2.3           Q-BIOLOGICALS shall not use the information and Materials referred
to in Articles 2.1 and 2.2 hereof received from COMPANY for any purpose other
than performing the Services hereunder. Said information and Materials shall at
all times remain the property of COMPANY.

 

2.4           Q-BIOLOGICALS shall not be liable for any loss or damage to
COMPANY Materials while in storage at the Facility, except if such loss or
damage is caused by the willful misconduct or gross negligence of Q-BIOLOGICALS
or its Personnel.

 

2.5           Q-BIOLOGICALS shall not be liable for any Defective Product (as
defined in Section 5.3) or for any Product not complying with the manufacturing
standards set forth in Article 1.2 to the extent such Defect or non-compliance
results solely from defective COMPANY Materials.

 

2.6           COMPANY acknowledges that on the Effective Date there are no
lawsuits, actions, administrative proceedings against COMPANY for infringing
third party patent and/or intellectual property rights. COMPANY further
acknowledges that on the Effective Date it is not aware of any third party
patent rights that would be infringed by COMPANY, or Q-BIOLOGICALS relating to
the information or Materials provided by COMPANY, or by Q-BIOLOGICALS performing
the Service in accordance with this Agreement.

 

Article 3
ASSIGNMENT - SUBCONTRACTING

 

3.1           Q-BIOLOGICALS shall not transfer, assign or subcontract this
Agreement or any of its rights and obligations under this Agreement, in whole or
in part, without the prior written agreement of COMPANY, which shall not be
unreasonably withheld; provided, however, in the event of a contemplated
transfer or assignment of this Agreement or of any of Q-BIOLOGICALS’ rights and
obligations under this Agreement to an acquirer of all or part of the business
to which this Agreement relates, COMPANY shall only be entitled to refuse its
agreement if the aforementioned transfer or assignment manifestly conflicts with
the legitimate interests of COMPANY or otherwise will have a material negative
impact on the quality of the Product.

 

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3.2           Contrary to the provisions of Article 3.1 hereof but subject to
the provisions of Section 3.3, it is agreed that Q-BIOLOGICALS may sub-contract
certain Services to the subcontractors approved by COMPANY listed in Annex 4
hereto.

 

3.3           Any subcontractor to which Q-BIOLOGICALS subcontracts any Services
pursuant to Section 3.1 (with the consent of COMPANY) or pursuant to Section 3.2
is referred to as an “Authorized Subcontractor.” Where required under cGMP
Q-BIOLOGICALS shall audit the Authorized Subcontractor and Q-BIOLOGICALS will
impose on each Authorized Subcontractor obligations no less strict than the ones
binding upon Q-BIOLOGICALS under this Agreement, and Q-BIOLOGICALS will remain
liable to COMPANY for any breach by such Authorized Subcontractor, as if such
breach had been committed by Q-BIOLOGICALS.

 

Article 4
CONSIDERATION

 

4.1           In consideration of the performance of the Services and of the
associated tasks defined herein, COMPANY shall pay Q-BIOLOGICALS the fixed price
(exclusive of VAT) set out in Annex 1 hereto. Q-BIOLOGICALS will provide COMPANY
with invoices at the intervals specified in said Annex 1.

 

4.2           COMPANY shall reimburse Q-BIOLOGICALS for the raw materials and
supplies in the quantities as defined in the batch records, as well as for the
other costs set out in Annex 1 hereto. Reimbursement of costs shall be subject
of separate invoices, which shall be accompanied by supporting documents and
which shall be sent to COMPANY on a regular basis during the Term.

 

4.3           COMPANY shall pay the invoices in Euro within thirty (30) days
from receipt by COMPANY of a written invoice from Q-BIOLOGICALS, specifying the
amount payable and the bank account number to which the payment should be made.
The invoice shall be sent to COMPANY at the address and the to the attention of
the person referred to in Article 12 or to any other address or person that may
be communicated by COMPANY to Q-BIOLOGICALS. Any invoice due which remains
unpaid by COMPANY after the due date shall bear an interest on a daily basis at
a rate equivalent to Libor one (1) month plus two percent (2%).

 

Article 5
STORAGE AND DELIVERY

 

5.1           Q-BIOLOGICALS shall store and warehouse all Materials received and
Products manufactured pursuant to this Agreement in the Facility in a secure and
clean area and compliant with Q-BIOLOGICALS’s Standard Operating Procedures. All
Materials and Products shall be clearly marked in such a way as to identify that
they are owned by COMPANY and for use only for or by COMPANY.

 

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5.2           Q-BIOLOGICALS shall deliver the Products manufactured under this
Agreement to COMPANY ex-works (lncoterms 2010) at Q-BIOLOGICALS’s Facility in
accordance with COMPANY’s directions (packaging, temperature, etc.). Said
delivery shall either take place promptly upon positive review by COMPANY of the
manufacturing batch records provided by Q-BIOLOGICALS to COMPANY or upon request
of COMPANY after storage of the Products at Q-BIOLOGICALS. Q-BIOLOGICALS shall
store the Products at Q-BIOLOGICALS’s Facility in qualified storage freezers,
free of charge for a maximum period of six (6) weeks after receipt of the
completed manufacturing batch records by COMPANY. After this six (6) weeks
period, Q-BIOLOGICALS will store the Products at a storage price of five hundred
Euro (500 €) per month for a maximum period of six (6) months.

 

The costs related to the storage shall be paid by COMPANY thirty (30) days from
the date of the invoice for such costs. After said six (6) month period,
Q-BIOLOGICALS will ship the Products to COMPANY or designated site at COMPANY’s
expense. Risk and title to the Products shall pass to COMPANY upon delivery of
the Products.

 

5.3           (a) COMPANY shall notify Q-BIOLOGICALS in writing (and provide
supporting documentation and samples of the delivery concerned to Q-BIOLOGICALS)
if it considers that any Products delivered hereunder is subject to a Defect (a
“Defective Product”), in which case the Parties shall immediately use good faith
efforts to agree whether or not such Products are Defective Products. As used in
this Agreement, “Defect” means the failure of any Product to conform in any
material respect to (i) the Specifications or (ii) any other requirement
(including manufacturing requirements) for such Product specified in this
Agreement (including, without limitation, Section 1.2) or the Quality Assurance
Agreement.

 

Any such notification by COMPANY to Q-BIOLOGICALS shall be done, in case of
visible Defect(s) (i.e. Defect(s) that could reasonably be detected upon proper
visual inspection), within thirty (30) days from the date of receipt of the
relevant shipment or, in case of hidden Defect(s) (i.e. defect(s) that could not
be reasonably detected upon proper visual inspection), within thirty (30) days
from the date of detection of the hidden Defect(s). Failure by COMPANY to notify
Q-BIOLOGICALS in writing within said timelines will constitute acceptance of the
Products by COMPANY and Q-BIOLOGICALS shall be released from any liability
towards COMPANY in relation to such Products

 

Q-BIOLOGICALS shall be entitled at all reasonable times to inspect and/or
analyze the Product delivery in question.

 

Q-BIOLOGICALS shall only be responsible for Defects that existed on or prior to
delivery to COMPANY. Q-BIOLOGICALS shall in no way be responsible for Defects
caused after the delivery thereof (such as, non-compliance that is caused by the
incorrect handling, storage and/or shipment of the Products after the delivery).
Q-BIOLOGICALS shall not be responsible for any Defect in the Products to the
extent such Defect (i) results from any non-compliance of or defect in the
COMPANY Materials, consumables, raw materials and/or components delivered by
COMPANY to Q-BIOLOGICALS, except to the extent Q-BIOLOGICALS was aware of such
defect or non-compliance and failed to advise COMPANY in accordance with this
Agreement.

 

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(b)          In the event that the Parties cannot agree as to whether any
Product is a Defective Product, the Parties shall appoint an independent
laboratory agreed upon between the Parties, who shall be instructed to determine
within sixty (60) days from its appointment whether such Products are Defective
Products and what the cause of such Defect is. The independent laboratory’s
decision shall be regarded as final settlement of the dispute and its decision
shall be binding upon the Parties. The costs of such laboratory shall be borne
by the Party against which the decision is rendered.

 

(c)          If, at the time of delivery, any Products are Defective Products,
Q-BIOLOGICALS will deliver replacement Products, or multiple replacement
deliveries until said Defect is resolved, of the Products to COMPANY as soon as
practicable at Q-BIOLOGICALS’s own cost, contingent upon receipt from COMPANY of
the COMPANY Materials, at COMPANY’s costs (except in the event the Defect
results from Q-BIOLOGICALS’s gross negligence, in which case Q-BIOLOGICALS will
bear the costs of the COMPANY Materials required for such replacement), in such
quantities needed for the replacement of the Products. COMPANY shall promptly
return to Q-BIOLOGICALS such Defective Products at Q-BIOLOGICALS’s expense.

 

Except for Q-BIOLOGICALS’s indemnification obligations pursuant to Article
9.2.1, any replacement of Products to which Q-BIOLOGICALS is obligated in
accordance with the above, shall constitute Q-BIOLOGICALS’s sole and exclusive
liability in relation to such Defective Products. Except for Q-BIOLOGICALS’s
indemnification obligations pursuant to Article 9.2.1, the liability of
Q-BIOLOGICALS to COMPANY in connection with any Defective Product shall not
exceed the cost of replacement thereof (such replacement costs including
shipping expenses of the Defective Products referred to above [and excluding any
and all costs related to COMPANY Materials]), except for liability arising from
gross negligence or willful misconduct of Q-BIOLOGICALS or its Personnel.

 

(d)          If any Defect is due to a change in the Products after delivery,
Q-BIOLOGICALS will deliver a replacement delivery of the Products to COMPANY as
soon as practicable at COMPANY’s cost and COMPANY shall, at its discretion
either keep or promptly return such Defective Products to Q-BIOLOGICALS at
COMPANY’s expense.

 

(e)          If any Defect is due to a hidden defect in the COMPANY Materials,
consumables, components and raw materials provided by COMPANY, Q-BIOLOGICALS
will deliver a replacement delivery of the Defective Products to COMPANY as soon
as practicable at COMPANY’s cost and COMPANY shall at its discretion either keep
or promptly return such Defective Products to Q-BIOLOGICALS at COMPANY’s
expense. COMPANY will be entitled to keep the retain samples of said Defective
Products.

 

Article 6
CONFIDENTIALITY

 

6.1          From time to time during the Term, either Party (as the “Disclosing
Party”) may disclose or make available to the other Party (as the “Receiving
Party”) information about its business affairs, products (including the
Products) and services, confidential information and materials comprising or
relating to intellectual property rights, trade secrets, third-party
confidential information and other sensitive or proprietary information. Such
information, as well as the terms of this Agreement, whether orally or in
written, electronic or other form or media, and whether or not marked,
designated or otherwise identified as “confidential” constitutes “Confidential
Information” hereunder. Confidential Information does not include information
that, at the time of disclosure and as established by documentary evidence:

 

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(a)          was known by or in the possession of the Receiving Party or its
Personnel prior to being disclosed by or on behalf of the Disclosing Party;

 

(b)          is or comes into the public domain other than as a result of,
directly or indirectly, the Receiving Party’s breach of this Article 6;

 

(c)          is or becomes available to the Receiving Party on a
non-confidential basis from a third-party source, provided that such third party
is not and was not prohibited from disclosing such Confidential Information;

 

(d)          was or is independently developed by the Receiving Party without
reference to or use of, in whole or in part, any of the Disclosing Party's
Confidential Information; or

 

(e)          is required to be disclosed by law, court order of a competent
jurisdiction or regulation, provided the Receiving Party, to the extent
permitted by law or regulation, consults with the Disclosing Party regarding the
contents of such disclosure prior thereto so that the Disclosing Party may have
a reasonable opportunity to take appropriate actions (if any) to preserve its
rights in the Confidential Information and to restrict to the maximum extent
legally possible the portion of Confidential Information to be disclosed.

 

6.2          During and after the Term, the Receiving Party shall (a) protect
and safeguard the confidentiality of the Disclosing Party’s Confidential
Information with at least the same degree of care as the Receiving Party would
protect its own Confidential Information, but in no event with less than a
commercially reasonable degree of care; (b) not use the Disclosing Party’s
Confidential Information, or permit it to be accessed or used, for any purpose
other than to exercise its rights or perform its obligations under this
Agreement; and (c) not disclose any such Confidential Information to any Person,
except to the Receiving Party’s Personnel who need to know the Confidential
Information to assist the Receiving Party, or act on its behalf, to exercise its
rights or perform its obligations under this Agreement. The Receiving Party
shall be responsible for any breach of this Article 6 caused by any of its
Personnel.

 

6.3          Upon termination of this Agreement, each Party shall destroy all of
the other Party’s Confidential Information which it has in its possession or
under its control and provide written proof thereof upon request or, if so
requested by the other Party, return the other Party’s Confidential Information.

 

Article 7
INTELLECTUAL PROPERTY

 

7.1          Rights to Background Technology.

 

Any and all technology, including but not limited to protocols, methods,
procedures, know-how and software, but excluding the Products, COMPANY Material
and COMPANY Technology which are owned by COMPANY, together with any
improvements thereof made by Q-Biologicals in the conduct of the Services
(hereafter “Q-BIOLOGICALS Technology”) and any and all biological material and
related information, related to the expression, purification, production and
analysis of proteins which will be used by Q-BIOLOGICALS in executing the
Services, including any parts or sub-units, descendants, progeny, mutants,
mutations or any other derivatives thereof (hereafter “Q-BIOLOGICALS Materials”)
shall exclusively be owned by Q-BIOLOGICALS, who shall have the right to protect
any such Q-BIOLOGICALS Technology and/or Q-BIOLOGICALS Material through
intellectual property rights.

 

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Nothing in this Agreement grants to COMPANY any rights to Q-BIOLOGICALS
Technology, Q-BIOLOGICALS Material or Q-BIOLOGICALS Confidential Information,
nor does this Agreement grant COMPANY licenses to any patent or patent
application comprising Q-BIOLOGICALS Technology, Q-BIOLOGICALS Material or
Q-BIOLOGICALS Confidential Information except as provided for in this Agreement.

 

Any and all biological material and related information, active and raw
materials, reagents, intermediates, processing aids, ingredients, components,
equipment, documentation and other materials delivered or made available by
COMPANY to Q-BIOLOGICALS, including any parts or sub-units, descendants,
progeny, mutants, mutations or any other derivatives thereof; together with any
improvements thereof made by Q-BIOLOGICALS in the conduct of the Services
(hereafter “COMPANY Materials”) and any and all technology and information
relating to the Product, owned or licensed by COMPANY that may be disclosed by
COMPANY or its Affiliates to Q-BIOLOGICALS prior to or during performance by
Q-BIOLOGICALS of the development activities hereunder (“COMPANY Technology”)
shall exclusively be owned by COMPANY, who has the right to protect any such
COMPANY Technology and/or COMPANY Material through intellectual property rights.

 

Nothing in this Agreement grants to Q-BIOLOGICALS any rights to the Products,
COMPANY Technology, COMPANY Material or COMPANY Confidential Information, nor
does this Agreement grant Q-BIOLOGICALS licenses to any patent or patent
application comprising COMPANY Technology, COMPANY Material or COMPANY
Confidential Information except as provided for in this Agreement.

 

7.2          Disclosure of Improvements.

 

Q-BIOLOGICALS shall promptly upon completion of the Services, disclose in the
reporting of the activities all new or improved process, technique, method,
formula, invention or know-how concerning the Product (hereafter “Product
Improvements”) and all new or improved generic process, strain, expression
cassette, plasmid, technique, method, formula, invention or know-how other than
Product Improvements. (hereafter “Technological Improvements”) conceived by
Q-BIOLOGICALS or of which it has become aware during the performance of the
activities under the Services.

 

7.3          Property of Product Improvements.

 

Product Improvements made either solely by Q-BIOLOGICALS or together with
COMPANY during the performance of this Agreement shall be the exclusive property
of COMPANY and COMPANY shall be free to seek patent protection as it deems
appropriate and to use the same without restriction throughout the world
including the right to grant sub-licenses. Q-BIOLOGICALS shall ensure the
transfer of rights as necessary free of charge.

 

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All intellectual property rights in Product Improvements made solely by COMPANY
during the performance of this Agreement shall remain the property of COMPANY
and shall only be used by Q-BIOLOGICALS for the sole purpose of performing
Services under this Agreement and in accordance with the terms hereof.

 

7.4          Property of Technological Improvements.

 

All intellectual property rights in Technological Improvements made either
solely by Q-BIOLOGICALS or together with COMPANY in the performance of this
Agreement shall be the exclusive property of Q-BIOLOGICALS and Q-BIOLOGICALS
shall be free to seek patent protection it deems appropriate and, to use the
same without restriction throughout the world, including the right to grant
licenses thereto. COMPANY shall ensure the transfer of rights as necessary free
of charge.

 

7.5          COMPANY herewith grants Q-BIOLOGICALS the right to use the COMPANY
Materials, COMPANY Technology and Product Improvements solely for the
performance of the Services during the terms of this Agreement.

 

Article 8
TERM AND TERMINATION

 

8.1          The Agreement shall remain in effect for a term (the “Term”)
commencing as of the Effective Date and, unless terminated earlier in accordance
with the provisions of this Agreement, continuing for three years (or such
extended date as may be agreed in writing by the Parties from time to time).

 

8.2          COMPANY shall have the right to terminate this Agreement at any
time for any reason with six (6) weeks prior written notice to Q-BIOLOGICALS.
This right of termination shall be without prejudice to any obligation COMPANY
shall have accrued and shall owe to Q-BIOLOGICALS prior thereto and it being
understood between the Parties that the 40% pre-payment (as set out in Annex 1)
paid by COMPANY to Q-BIOLOGICALS after signing this Manufacturing Services
Agreement is non-refundable in the case of a termination pursuant to this
Section 8.2 (but not in the case of a termination by COMPANY pursuant to Section
8.3.

 

8.3          Each Party shall have the right to terminate this Agreement
forthwith by written notice to the other Party if the other Party commits a
material breach of this Agreement, provided the terminating Party gave the other
Party notice of the breach which has not been cured within a period of thirty
(30) days after receipt of the notice.

 

8.4         Upon any termination or expiration of this Agreement:

 

8.4.1           The following Articles of this Agreement shall continue in
force: 6, 7, 8.4, and 9 to 12.

 

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8.4.2           Q-BIOLOGICALS shall deliver promptly to COMPANY (and/or, at
COMPANY’s request, store at Q-BIOLOGICALS’s premises for up to six (6) weeks)
and COMPANY shall compensate Q-BIOLOGICALS for (a) all work-in-progress
commenced by Q-BIOLOGICALS up to such point in time (including for the avoidance
of doubt all documentation, batch records); (b) all finished Products
manufactured by Q-BIOLOGICALS, and (c) all consumables, raw materials and
components (i) received by Q-BIOLOGICALS for the purposes of this Agreement
prior to termination or (ii) ordered by Q-BIOLOGICALS for the purposes of this
Agreement prior to its delivery or receipt of notice of termination but not
received until after termination, if such order is not cancellable.

 

Article 9
REPRESENTATION AND WARRANTIES, LIABILITY,
INDEMNIFICATION AND INSURANCE

 

9.1         Representations and Warranties.

 

9.1.1           Except for the representations and warranties explicitly granted
by Q-BIOLOGICALS or COMPANY in this Agreement, Q-BIOLOGICALS AND COMPANY MAKE NO
OTHER WARRANTIES OR REPRESENTATION OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY
PARTICULAR PURPOSE, OR ANY OTHER MATTER WITH RESPECT TO THE PRODUCT.

 

9.1.2           Each Party hereby represents and warrants to the other Party as
follows:

 

(a)          Organization. It is a duly organized and validly existing
corporation, as applicable, in good standing under the laws of its jurisdiction.

 

(b)          Authorization. It has full power and authority to enter into this
Agreement and to perform its obligations hereunder. It has taken all action
required by any applicable law, its organizational documents or otherwise to
authorize the execution and delivery of this Agreement. This Agreement
constitutes a valid and binding agreement of the representing Party, and the
execution, delivery and performance of this Agreement by the representing Party
are within the representing Party’s corporate or institutional power, as
applicable, and have been duly authorized by all necessary corporate or
institutional action, as applicable.

 

9.1.3           Q-BIOLOGICALS represents and warrants to COMPANY that on the
Effective Date there are no lawsuits, actions, administrative proceedings
against Q-BIOLOGICALS for infringing third party patent and/or intellectual
property rights.

 

9.2         Liability and Indemnification.

 

9.2.1           Subject to the limitations and exclusions of liability set forth
in this Agreement, Q-BIOLOGICALS shall indemnify, defend and hold COMPANY, and
their affiliates and their respective officers, directors, employees and agents
(each, an “COMPANY Indemnified Party”) harmless from and against any and all
claims, demands or lawsuits instituted by a third party against a COMPANY
Indemnified Party to the extent arising out of (1) a material breach of this
Agreement caused by, or the negligence or willful misconduct of, Q-BIOLOGICALS
or its Personnel (including Authorized Subcontractors); (2) the material breach
by Q-BIOLOGICALS of its representations, warranties or covenants contained in
this Agreement; or (3) Q–BIOLOGICAL’s background intellectual property
(including, without limitation, Q-BIOLOGICAL Materials and Q-BIOLOGICAL
Technology) used for the performance of the Services infringing any third party
intellectual property rights; in each case save for any event for which COMPANY
is obligated to indemnify Q-BIOLOGICALS under this Agreement.

 

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9.2.2           Subject to the limitations and exclusions of liability set forth
in this Agreement, COMPANY shall indemnify, defend and hold Q-BIOLOGICALS and
its affiliates and its respective officers, directors, employees and agents
(each, a “Q-BIOLOGICALS Indemnified Party”) harmless from and against any and
all claims, demands or lawsuits instituted by a third party against a
Q-BIOLOGICALS Indemnified Party to the extent arising out of (1) a material
breach of this Agreement caused by, or the negligence or willful misconduct of,
COMPANY or its Personnel; (2) the material breach by COMPANY of its
representations, warranties or covenants contained in this Agreement; (3)
COMPANY’s use (including, but not limited to, in clinical trials) of the
Product(s) that are subject of the Services; or (4) the use of COMPANY’s
Background Intellectual Property, including but not limited to COMPANY
Materials, by Q-BIOLOGICALS infringing any third party intellectual property
rights; in each case save for any event for which Q-BIOLOGICALS is obligated to
indemnify COMPANY under this Agreement.

 

9.2.3           If and to the extent the injury or liability is caused by the
negligence of both Q-BIOLOGICALS and the COMPANY, the apportionment of said
damages shall be shared between Q-BIOLOGICALS and COMPANY based upon the
comparative degree of each other’s negligence, and each Party shall be
responsible for its own defense and costs including but not limited to the cost
of defense, attorneys’ fees and witnesses’ fees and expenses incident thereto.

 

9.2.4           Notwithstanding any other provision in this Agreement and except
for Q-BIOLOGICALS’s indemnification obligation set forth in Article 9.2.1,
Q-BIOLOGICALS’s maximum liability under or in relation to this Agreement towards
COMPANY and its affiliates shall be limited to the aggregate amount of payments
received by Q-BIOLOGICALS from COMPANY pursuant to Article 4 hereof during the
period of twelve (12) month preceding the event giving rise to the claim. For
the avoidance of any doubt, multiple replacement deliveries to resolve the same
non-compliance matter shall be counted as one replacement delivery. This
limitation of liability shall not apply for claims arising from Q-BIOLOGICALS’s
willful misconduct or gross negligence. Parties agree that product liability in
respect of the Products shall remain at all times with COMPANY and Q-BIOLOGICALS
shall have no liability towards COMPANY in relation to and shall have no
obligation to indemnify or hold COMPANY harmless for any product liability
arising for Products manufactured by Q-BIOLOGICALS under this Agreement, except
to the extent caused by the gross negligence or willful misconduct of
Q-BIOLOGICALS or its Personnel.

 

9.2.5           Except to the extent included in third party claims referred to
under Articles 9.2.1 and 9.2.2, neither Party nor its affiliates, employees,
agents, officers, and directors will be liable to the other Party for any
incidental, special, consequential or punitive damages or amounts for loss of
income, profits or savings arising out of or relating to its performance or
failure to perform under this Agreement, regardless of the basis on which a
Party is entitled to claim damages, whether in contract or tort.

 

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9.2.6           Nothing in this Agreement shall limit either Party’s liability
for (1) fraud or intentional misconduct, (2) any claim relating to a breach of
confidentiality; and (3) any other liability which cannot lawfully be limited or
excluded.

 

9.3         Insurance.

 

9.3.1           Both Parties shall throughout the Term maintain at their own
cost insurance to cover their respective liabilities hereunder. Each Party shall
upon request of the other Party provide such Party with such documentary
evidence of said insurance as the other Party may reasonably require, including
evidence that the last premium due has been duly paid.

 

Article 10
INDEPENDENT CONTRACTOR

 

Q-BIOLOGICALS shall act at all times as an independent contractor hereunder.
Nothing in this Agreement shall be construed as to give Q-BIOLOGICALS the power
of authority to act for, bind or commit COMPANY.

 

Article 11
APPLICABLE LAW, JURISDICTION

 

This Agreement shall be construed and interpreted in accordance with the laws of
Belgium. Any dispute concerning the validity, the interpretation or the
performance of this Agreement which cannot be settled amicably, shall be
submitted to the competent courts of Brussels (Belgium).

 

Article 12
MISCELLANEOUS

 

12.1         Schedules. The Annexes attached to this Agreement form an integral
part of this Agreement. In the event of a contradiction between the provisions
of this Agreement and those of its Annexes, the provisions of this Agreement
shall prevail.

 

12.2         Waiver. No waiver of any rights shall be effective unless consented
to in writing by the Party to be charged and the waiver of any breach of default
shall not constitute a waiver of any other right hereunder or any subsequent
breach or default.

 

12.3         Compliance with Laws. In exercising their rights under this
Agreement, the Parties shall fully comply in all material aspects with the
requirements of any and all applicable laws, regulations, rules and orders of
any governmental body having jurisdiction over the exercise of rights under this
Agreement. Each Party shall be responsible, at its own expense, for making any
required registrations or filings with respect to this Agreement and obtaining
any necessary governmental approvals with respect hereto.

 

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12.4         Entire Agreement; Amendment. This Agreement and the Quality
Assurance Agreement constitute the entire Agreement between the Parties with
respect to the subject matter hereof and supersede and cancel all previous
discussions, agreements, commitments and writings in respect, provided, however,
that the Confidentiality Agreement dated December 15, 2015 by and between
COMPANY and Q-BIOLOGICALS remains in full force and effect. No amendment or
addition to this Agreement shall be effective unless reduced to writing and
executed by the authorized representatives of the Parties.

 

12.5         Force Majeure. Neither Party shall be held in breach of its
obligations hereunder to the extent only that due performance or observance of
such obligation is prevented or delayed by reason of war and other hostilities,
civil commotion, accident, strikes, lock-outs, trade disputes, acts or
restraints of government imposition or restrictions of imports or exports or any
other cause not within the control of the Party concerned. The Party concerned
shall forthwith notify the other Party of the nature and effect of such event
and both Parties shall, where the same is practicable, use every reasonable
endeavour to minimize such effect and to comply with the respective obligation
herein contained as nearly as may be in their original form.

 

12.6         Assignment. Q-BIOLOGICALS may not assign this Agreement or any part
of its rights or obligations under this Agreement without the prior written
consent of COMPANY. COMPANY may assign this Agreement as part of a sale or
change of control, regardless of whether such a sale or change of control occurs
through an asset sale, stock sale, merger or other combination, or any other
transfer of (a) COMPANY’s entire business; or (b) that part of COMPANY’s
business that exercises all rights granted under this Agreement. Upon a
permitted assignment of this Agreement, COMPANY shall be released of liability
under this Agreement and the term “COMPANY” in this Agreement will mean the
assignee.

 

12.7         Severability. In the event one or more of the provisions of this
Agreement should for any reason be held by any court or authority having
jurisdiction over this Agreement or any of the Parties hereto be invalid,
illegal or unenforceable, such provision(s) shall be validly reformed to as
nearly approximate the intent of the Parties as possible and if unreformable,
the Parties shall meet to discuss what steps should be taken to remedy the
situation; elsewhere, this Agreement shall not be affected.

 

12.8         Notices. Except as otherwise explicitly provided in this Agreement,
all notices, requests, reports and other communications provided in this
Agreement shall be in writing and shall be deemed to have been made or given:
(a) when delivered, if delivered by hand; (b) when confirmation of transmission
received, if sent by facsimile or the like; (c) two (2) days following deposit
with an overnight courier; or (d) on the date three (3) business days following
deposit, as certified or registered mail, with the postal service of the country
of the Party providing notice:

 

To COMPANY:

Propanc Health Group Corporation

Attn: James Nathanielsz

555 Riversdale Road

Camberwell, Victoria, 3124

Australia

 

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To Q-BIOLOGICALS:  

Dr. Annie Van Broekhoven

CEO

Q-Biologicals NV

Technologiepark 4

9052 Zwijnaarde

Belgium

Tel. +32 475 96 60 70

 

The above addresses may be altered by notice given in accordance with this
section.

 

12.9       Headings. The headings of the various provisions of this Agreement
are used solely for the convenience of the Parties, do not form a part of this
Agreement and are not intended to affect the interpretation or meaning of this
Agreement or to define, limit, extend or describe its scope or intent.

 

Remainder of page left intentionally blank

 

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed in
duplicate by their duly authorized representatives; each Party receiving one
original.

 

Q-BIOLOGICALS       /s/ Annie Van Broekhoven   Signature       By:

CreaBioSupport BVBA

represented by Annie Van Broekhoven

    Title: CEO   Date: 22/08/2016  

 

Q-BIOLOGICALS           Signature  

 

By:

Karine Clauwaert

On behalf of Yves Gonnissen

    Title: Director Business Development Q-Biologicals   Date: 22/08/2016  

 

Propanc Health Group Corporation       /s/ James Nathanielsz   Signature  

 

By: James Nathanielsz   Title: CEO   Date: August 12th, 2016  

 

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