Document:

Exhibit 10.8

 

Execution
Copy

 

FIRST
AMENDMENT TO

DISTRIBUTION AGREEMENT

BETWEEN

OASMIA PHARMACEUTICAL AB AND ABBOTT LABORATORIES

 

This
First Amendment (“First Amendment”) to the Distribution Agreement, dated as of July 8, 2009, between Abbott Laboratories,
an Illinois corporation (“Abbott”), and Oasmia Pharmaceutical AB, a Swedish corporation (“Oasmia”) (the
“Original Agreement”), is effective as of December ___, 2012 (“First Amendment Effective Date”). Any capitalized
term used and not otherwise defined herein shall have the meaning set forth in the Original Agreement.

 

RECITALS

 

WHEREAS,
the Parties desire to amend the Original Agreement to, among other things, (a) add an additional Product; (b) expand the scope
of the Territory; (c) collaborate on Development activities for the Products; (d) revise certain milestone payments; and (e) address
certain marketing and regulatory matters.

 

NOW,
THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties hereto, intending
to be legally bound, hereby agree to amend the Agreement as follows:

 

1.          The
following defined terms in Clause 1 of the Agreement are hereby amended as follows:

 

A.           Clause
1.6 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Calendar
Quarter” shall mean with respect to the activities of Abbott and its Affiliates, each three month period commencing January
1, April 1, July 1 or October 1 of each year during the Term.”

 

B.           Clause
1.11 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Development
Plan” shall mean the pre-clinical, clinical and pharmaceutical development plan for each Product, which sets forth the activities,
timetables and budget for the Development of such Product in the Field, as created by the JDC and approved by the JSC, as such
plan may be amended from time to time in accordance with the terms of this Agreement.”

 

C.           Clause
1 of the Agreement is hereby amended by adding the following as Clause 1.11A:

 

““EC
Directive” shall mean the EC Directive 2001/82/EC (2001) as amended by Directive 2004/28/EC (2004), the Annex to Directive
2001/82/EC and any amendments thereto and/or successor or directive thereto governing manufacturing of veterinary products for
the European Union.”

 

    	 

    	 

    

  

D.           Clause
1 of the Agreement is hereby amended by adding the following as Clause 1.11B:

 

““EMA”
shall mean collectively or individually, as the context requires, the European Medicines Agency, the Committee for Medicinal Products
for Veterinary Use (CVMP) and the European Commission.”

 

E.           Clause
1.14 of the Agreement is hereby deleted in its entirety and replaced with “[Intentionally Omitted]”.

 

F.           Clause
1.16 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Marketing
Authorization” shall mean, for any regulatory jurisdiction in the Territory, all marketing and other authorizations and
approvals by the applicable Regulatory Authority necessary for the lawful importation, promotion, distribution, use, marketing
and sale of the Product in that regulatory jurisdiction, and with respect to the United States of America, specifically excluding
Conditional Approval.”

 

G.           Clause
1.20 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Oasmia
Trademark” shall mean Oasmia’s trademarks Doxophos Vet and Paccal Vet.”

 

H.           Clause
1.21 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Product”
shall mean Paccal Vet and Doxophos Vet, individually or collectively as applicable, in final sellable form, as further described
in Appendix 1.21, and any revised, improved, derivative, replacement or successor products thereto for use in the Field, or any
pharmaceutical preparations that contain or comprise the Compounds as the active ingredient. Abbott acknowledges and agrees that
Carbomexx and Docecal are examples of products that would not fall within the definition of “Product” because they
are not revised, improved, derivative, replacement or successor products to Paccal Vet or Doxophos Vet, nor do they contain or
comprise any of the Compounds as the active ingredient.”

 

I.           Clause
1.23 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Regulatory
Authority” shall mean any federal, state, local or international regulatory agency, department, bureau, governmental commission,
body, court or other state or federal agency or entity of the U.S. or any foreign government, including FDA and/or EMA and/or
competent authority in the Territory, which (a) is responsible for issuing approvals, licenses, registrations, clearances or authorizations
necessary for the manufacture, use, storage, import, transport or sale of Product in a regulatory jurisdiction; (b) is where Product-related
safety or efficacy issues, including recalls or field alerts are reported to under applicable law; or (c) otherwise have jurisdiction
over the manufacture, use, storage, import, transport, promotion and/or sale of Product in a regulatory jurisdiction.”

 

    	2

    	 

    

  

J.           Clause
1.26 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

““Territory”
shall mean worldwide, except for (i) the countries of Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova,
Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine with respect to Paccal Vet (as such Product is described in Appendix
1.21) and Doxophos Vet (as such Product is described in Appendix 1.21) and (ii) Japan with respect to Paccal Vet (as such Product
is described in Appendix 1.21).”

 

2.          Clause
2.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Oasmia
hereby appoints Abbott and Abbott hereby accepts the appointment as the exclusive distributor with the exclusive right, even as
to Oasmia, to import, promote, market, distribute, offer for sale, sell, and have sold (together, “Distribution”)
the Product in the Territory for the Field during the Term, using Oasmia Patent Rights, Oasmia Proprietary Rights, Improvements
and the Oasmia Trademark. Abbott shall refrain from marketing and/or actively selling the Product outside the Territory or selling
the Product to a third party that Abbott knows or should reasonably know will use, resell, redistribute or otherwise transfer
to a country outside the Territory.”

 

3.          Clause
2.2 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“2.2           Except
in the event that this Agreement is terminated or such exclusivity becomes illegal due to the law of a jurisdiction in the Territory,
neither Oasmia nor its Affiliates shall during the Term:

 

2.2.1           appoint
any third party as a distributor of Product in the Territory for the Field or otherwise grant any third party the right to use,
import, offer for sale and/or sell any Product in the Territory;

 

2.2.2           make
or sell, or permit or license any third party to make or sell, Product in the Territory for the Field;

 

2.2.3           promote
or market any Product for use in the Territory for the Field;

 

2.2.4           sell
any Product that it knows or should reasonably know will be used in the Territory for the Field;

 

2.2.5           sell
any Product to a distributor or end user where it knows or should reasonably know that such distributor or end user intends to
use such Product in the Territory for the Field;

 

    	3

    	 

    

  

2.2.6           sell
any Product to an end user or other third party (including a distributor) that it knows or should reasonably know will redistribute
Products or otherwise direct Products for use to customers in the Territory for the Field;

 

2.2.7           resell
or otherwise transfer or exchange Products to any parties identified by Abbott or Oasmia as diverters; or

 

2.2.8           fail
to take all steps reasonably necessary to prevent unauthorized parties from distributing Products.

 

Upon
Abbott’s request, if and to the extent Oasmia or its Affiliates violate any of the foregoing restrictions, Oasmia shall
remit to Abbott an amount equal to one hundred and twenty percent (120%) of Abbott’s lost profit. Such lost profit shall
be calculated as the additional amount of Net Sales Abbott would have achieved less the Supply Price of the additional amount
of Products that Abbott would have sold, and less the additional amount of Royalty Abbott would have owed, had there not been
a violation of the foregoing restrictions.

 

If
the foregoing exclusivity becomes illegal due to the law of a jurisdiction in the Territory, only those portions of the foregoing
exclusivity that become illegal with respect to such jurisdiction in the Territory shall be invalid, void and unenforceable, and
the remaining portions of the foregoing exclusivity shall remain in full force and effect and shall in no way be affected, impaired
or invalidated thereby.”

 

4.          Clauses
2.3, 2.4 and 2.7 of the Agreement are hereby amended by deleting the words “and Doxophos”.

 

5.          Clause
2.8 of the Agreement is hereby deleted in its entirety.

 

6.          Clause
3 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“3          COLLABORATION
MANAGEMENT

 

3.1          Joint
Commercialization Management

 

(a)          Within
sixty (60) days after the First Amendment Effective Date, the Parties shall initiate a Joint Commercialization Management Committee
(the “JCMC”) to oversee the overall strategy of the commercialization, marketing and new market launches of the Products. 

 

(b)          The
JCMC shall meet at least twice every calendar year, on such date and at such time as agreed to by the Parties, with all scheduled
in-person meetings to alternate between Party sites, or at other locations as determined by the JCMC or be held by teleconference
or other suitable remote meeting system, if agreed by the Parties. In addition, either Party may convene a special meeting of
the JCMC on no less than ten (10) days’ prior written notice, and such special meetings may be held by audio or video conference
with the consent of each Party.   Each Party shall be responsible for its own expenses for participating in the JCMC. 
Meetings of the JCMC shall be effective only if at least one representative of each Party is present or participating. 

 

    	4

    	 

    

  

3.2          Joint
Steering Committee

 

(a)          As
of the First Amendment Effective Date, the Parties shall create a Joint Steering Committee (the “JSC”) to oversee
the overall strategy of the Development of the Product and carry out the functions described in this Clause 3.

 

(b)          The
role of the JSC is to ensure obligations and responsibilities under this Agreement are upheld by both Parties.  The JSC will
also provide the necessary support and resources to the JDC (as defined below) as needed. Accordingly, the JSC shall among other
things (i) review and approve the Development Plan and commercialization plans for each Product, and revisions thereto submitted
to it by the JDC  as soon as reasonably practicable after receipt thereof; (ii) make decisions about funding of Product and
Clinical development, including development of all relevant study protocols; (iii) attempt to resolve disputes or disagreements
arising in the JDC; and (iv) perform such other functions as the Parties may agree in writing or as otherwise assigned
by the Agreement.

 

(c)          Each
Party shall designate one (1) or two (2) representatives who are employees of such Party or an Affiliate of such Party with appropriate
expertise to serve as members of the JSC. Each Party may replace any or all of its representatives at any time upon prior written
notice to the other Party. The initial members of the JSC shall be Julian Aleksov, designated by Oasmia, and Andrea Wainer, designated
by Abbott.

 

(d)          In
the event of a dispute between the Parties in the JSC that cannot be resolved by the JSC, the dispute shall be binding on the
Parties and resolved by binding Alternative Dispute Resolution (“ADR”) in the manner described in Appendix 24.1.

 

(e)          Decisions
by the JSC shall be documented in meeting minutes and formally signed by representatives from both Parties within ten (10) days
from the meeting. In the event and to the extent any decisions by the JSC constitute a change or amendment to the Agreement, the
Parties shall work in good faith to implement such changes and revise, amend, supplement or modify the Agreement accordingly,
as the case may be.

 

(f)          The
JSC shall meet at least once every calendar year, on such date and at such time as agreed to by the Parties, with all scheduled
in-person meetings to alternate between Party sites, or at other locations as determined by the JSC or be held by teleconference
or other suitable remote meeting system, if agreed by the Parties. In addition, either Party may convene a special meeting of
the JSC by no less than ten (10) days’ prior written notice. Meetings may be held by audio or video conference with the
consent of each Party. Each Party shall be responsible for its own expenses for participating in the JSC. Meetings of the JSC
shall be effective only if at least one representative of each Party is present or participating.

 

    	5

    	 

    

  

3.3          Joint
Development Committee

 

(a)          Within
sixty (60) days after the First Amendment Effective Date, the Parties shall create a Joint Development Committee (the “JDC”)
to oversee the Development Plan of the Product. The JDC shall develop the strategies for and oversee the Development of the Product
in the Territory.

 

(b)          Each
Party shall designate representatives who are employees of such Party or an Affiliate of such Party (not to exceed six (6) for
each Party) with appropriate expertise to serve as members of the JDC. Each Party may replace any or all of its representatives
at any time upon prior written notice to the other Party. Each Party shall designate one of its representatives as a co-chair
of the JDC. The duties of each co-chair of the JDC shall be (i) scheduling meetings of the JDC, (ii) preparing an agenda for each
meeting, (iii) leading the JDC in each meeting, and (iv) preparing the minutes from each meeting.

 

(c)          The
JDC shall among other things (i) develop, within sixty (60) days of formation of the JDC, a comprehensive revised Development
Plan for each Product; (ii) periodically (no less often than biannually) review the Development Plan, and review and approve amendments
thereto for approval by the JSC; (iii) serve as a forum for discussing proposed Development activities for each respective Party;
(iv) resolve any disputes regarding Development activities; (v) oversee and ensure the conduct of Development activities under
the Development Plan; (vi) serve as a forum for discussing and coordinating strategies (including prioritization and timelines)
for obtaining Marketing Authorization for the Product in the Territory; and (vii) perform such other functions as are set forth
herein or as the Parties may mutually agree in writing, except where in conflict with any provision of the Agreement.

 

(d)          No
later than April 30, 2013, the JDC shall approve the Paccal Vet Second Source Manufacturer Plan.

 

(e)          In
the event of a dispute between the Parties in the JDC that cannot be resolved in the JDC, the dispute will be raised to the JSC
for resolution.

 

(f)          The
JDC shall meet as frequently as members of the JDC determine is required (but in no event, less frequently than every other month
during the first calendar year following the First Amendment Effective Date and once every calendar quarter thereafter), on such
dates and at such times as agreed to the Parties, with all scheduled in-person meetings to alternate between sites as designated
by the respective Party prior to such meeting, or at other locations as determined by the JDC, or be held by teleconference or
other suitable remote meeting system, if agreed by the Parties. In addition, either Party may convene a special meeting of the
JDC by no less than ten (10) days’ prior written notice. Meetings may be held by audio or video conference with the consent
of each Party. Each Party shall be responsible for its own expenses for participating in each JDC meeting. Meetings of the JDC
shall be effective only if more than one-half of the total representatives of each Party are present or participating. Decisions
by the JDC shall be minuted and formally signed by representatives from both Parties within ten (10) days from the meeting.”

 

    	6

    	 

    

  

7.          Clause
4.3 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Oasmia
shall file the Marketing Authorization applications for the Product in each regulatory jurisdiction in the Territory in accordance
with the strategy and timeline developed by the JDC and approved by the JSC, and shall use commercially reasonable efforts to
ensure that the Registration Dossier and the application for the Marketing Authorization in each regulatory jurisdiction (a) have
been compiled and filed for according to the requirements of applicable laws and regulations, and (b) have been compiled in such
a way and in such form as is required by the applicable Regulatory Authority, in order for them to accept such application and
to grant Marketing Authorization thereon.”

 

8.          Clause
4.5 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Oasmia
shall prepare all Marketing Authorization applications relevant to the applicable Regulatory Authority in the United States, Canada
and the European Union. For all other countries in the Territory, Abbott shall use commercially reasonable efforts to assist Oasmia
in identifying those countries where such applications need to be made and shall also assist Oasmia in connection with preparing
such applications. Prior to submission to a Regulatory Authority Oasmia shall submit a copy of a Basic Registration Dossier in
English language to Abbott including any other necessary documents relating to the Product specific Marketing Authorization application,
Abbott shall review, comment and approve such documentation prior to submission. Abbott shall provide any relevant comments in
writing to Oasmia within thirty (30) days of receipt thereof from Oasmia. Abbott shall be deemed to have approved such documentation
for purposes of such review unless Abbott provides in writing to Oasmia its comments, in reasonable detail, within such time period.
Upon receipt of comments from Abbott, Oasmia shall incorporate revisions requested to such documentation by Abbott as a result
of Abbott’s review, provided, the revisions are required to comply with applicable regulatory standards. Oasmia shall arrange
with translation of a file to the appropriate language required for the submission.”

 

9.          Clause
5 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“5.1.AIn
July 2009, Abbott made a milestone payment to Oasmia in the sum of Five Million Dollars ($5,000,000) pursuant to Clause 5.1(a)
of the Original Agreement. Pursuant to Section 5.3 of the Original Agreement, in the event that Oasmia fails to achieve the Marketing
Authorization Milestone (as defined in the Original Agreement) on or before May 1, 2014, then Oasmia would have to immediately
pay to Abbott a Two Million Dollar ($2,000,000) partial refund of the $5,000,000 milestone payment (the “Refund”).
Effective as of the First Amendment Effective Date, the Parties acknowledge, agree and covenant that the Refund shall not be owed
by Oasmia to Abbott in any circumstance or event.

 

    	7

    	 

    

  

5.1.BEffective
as of the First Amendment Effective Date, the sum of Six Hundred Fifty Thousand Dollars ($650,000) shall be paid by Abbott to
Oasmia within ten (10) days of the First Amendment Effective Date.

 

5.2         Subject
to the terms and conditions below, an additional milestone payment shall become payable by Abbott to Oasmia after (a) Oasmia obtains
Marketing Authorizations for Paccal Vet in the United States for treatment of squamous cell carcinoma (“SCC”) or treatment
of mast cell tumors (“MCT”), and in the European Union for treatment of SCC or treatment of MCT or treatment of mammary
cancer and (b) Oasmia achieves execution of a manufacturing site transfer to a third-party manufacturer (the “Paccal Vet
US/EU Marketing Authorization Milestone”), and shall be paid by Abbott within forty-five (45) days from receipt of Oasmia’s
documentation evidencing the achievement of the Paccal Vet US/EU Marketing Authorization Milestone. The JDC shall prioritize which
indications should be pursued in obtaining the Marketing Authorizations in the United States and European Union for Paccal Vet.
The amount of the Paccal Vet US/EU Marketing Authorization Milestone payment will be calculated as follows: if Oasmia achieves
the Paccal Vet US/EU Marketing Authorization Milestone on or before June 30, 2018 the payment will equal Two Million Dollars ($2,000,000);
after such date the payment will be reduced by Two Hundred Fifty Thousand Dollars ($250,000) and will be reduced by an additional
Two Hundred Fifty Thousand Dollars ($250,000) every six (6) months thereafter until Oasmia achieves the Paccal Vet US/EU Marketing
Authorization Milestone. Accordingly, in the event that Oasmia fails to achieve the Paccal Vet US/EU Marketing Authorization Milestone
on or before December 31, 2021, it will not be entitled to receive a Paccal Vet US/EU Marketing Authorization Milestone payment.

 

5.3         Subject
to the terms and conditions below, an additional milestone payment shall become payable by Abbott to Oasmia after Oasmia obtains
Conditional Approval for Doxophos Vet (the “Doxophos Vet Conditional Approval Milestone”), and shall be paid by Abbott
within forty-five (45) days from receipt of Oasmia’s documentation evidencing the achievement of the requirements of the
Doxophos Vet Conditional Approval Milestone. The amount of the Doxophos Vet Conditional Approval Milestone payment will equal
Five Hundred Thousand Dollars ($500,000).

 

5.4.A    Subject
to the terms and conditions below, an additional milestone payment shall become payable by Abbott to Oasmia after Oasmia obtains
the Marketing Authorization for Doxophos Vet in the United States with an indication for treatment of canine lymphoma (the “Doxophos
Vet US Marketing Authorization Milestone”), and shall be paid by Abbott within forty-five (45) days from receipt of Oasmia’s
documentation evidencing the achievement of the Doxophos Vet US Marketing Authorization Milestone. The amount of the Doxophos
Vet US Marketing Authorization Milestone payment will be calculated as follows: if Oasmia achieves the Doxophos Vet US Marketing
Authorization Milestone on or before June 30, 2020 the payment will equal Seven Hundred Fifty Thousand Dollars ($750,000); after
such date the payment will be reduced by One Hundred Fifty Thousand Dollars ($150,000) and will be reduced by an additional One
Hundred Fifty Thousand Dollars ($150,000) every six (6) months thereafter until Oasmia achieves the Doxophos Vet Marketing Authorization
Milestone. Accordingly, in the event that Oasmia fails to achieve the Doxophos Vet US Marketing Authorization Milestone on or
before June 30, 2022, it will not be entitled to receive a Doxophos Vet US Marketing Authorization Milestone payment.

 

    	8

    	 

    

  

5.4.B    Subject
to the terms and conditions below, an additional milestone payment shall become payable by Abbott to Oasmia after Oasmia obtains
the Marketing Authorization for Doxophos Vet in the European Union with an indication for treatment of canine lymphoma (the “Doxophos
Vet EU Marketing Authorization Milestone”), and shall be paid by Abbott within forty-five (45) days from receipt of Oasmia’s
documentation evidencing the achievement of the Doxophos Vet EU Marketing Authorization Milestone. The amount of the Doxophos
Vet EU Marketing Authorization Milestone payment will be calculated as follows: if Oasmia achieves the Doxophos Vet EU Marketing
Authorization Milestone on or before June 30, 2020 the payment will equal Two Hundred Fifty Thousand Dollars ($250,000); after
such date the payment will be reduced by an additional Fifty Thousand Dollars ($50,000) and will be reduced by Fifty Thousand
Dollars ($50,000) every six (6) months thereafter until Oasmia achieves the Doxophos Vet EU Marketing Authorization Milestone.
Accordingly, in the event that Oasmia fails to achieve the Doxophos Vet EU Marketing Authorization Milestone on or before June
30, 2022, it will not be entitled to receive a Doxophos Vet EU Marketing Authorization Milestone payment.

 

5.5       Effective
as of the First Amendment Effective Date, and in consideration to Oasmia for the rights granted to Abbott hereunder and for Oasmia’s
compliance with the terms and conditions hereof, Abbott shall make milestone payments to Oasmia as follows:

 

		(a)	The
                                         sum of Four Million Dollars ($4,000,000) shall become payable by Abbott to Oasmia when
                                         the calendar year Net Sales reach Twenty-Five Million Dollars ($25,000,000) for the first
                                         time and shall be paid by Abbott within ninety (90) days of milestone achievement.

 

		(b)	The
                                         sum of Six Million Dollars ($6,000,000) shall become payable by Abbott to Oasmia when
                                         the calendar year Net Sales reach Fifty Million Dollars ($50,000,000) for the first time
                                         and shall be paid by Abbott within ninety (90) days of milestone achievement.

 

		(c)	The
                                         sum of Eight Million Dollars ($8,000,000) shall become payable by Abbott to Oasmia when
                                         the calendar year Net Sales reach Seventy-Five Million Dollars ($75,000,000) for the
                                         first time and shall be paid by Abbott within ninety (90) days of milestone achievement.

 

10.         Clause
6 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“FORECASTING
AND ORDERING

 

6.1           Six
(6) months ahead of the estimated date of the first Regulatory Approval as determined by the Joint Development Committee, the
Parties shall hold a meeting or teleconference to discuss the forecasting, ordering, and manufacturing processes, including lead
times for raw materials and appropriate means of communication between the Parties for planning and ordering issues.
Within sixty (60) days after the date of the first Regulatory Approval, Abbott will furnish to Oasmia a nonbinding Long
Range Supply Plan covering the next two (2) years.  Each coming year thereafter Abbott will provide an updated nonbinding
Supply Plan to Oasmia in the month of June covering the next two (2) year period.

 

    	9

    	 

    

  

6.2           Oasmia
shall, during the Term, manufacture and deliver such quantities of Product which are ordered by Abbott in writing. Abbott shall
place firm purchase orders with Oasmia on or before the fifteenth (15th) day of each
month and no later than the Minimum PO Lead Time prior to Abbott’s requested delivery date. The purchase orders that
Abbott places for delivery in any given month shall be in an amount that is not less than eighty percent (80%) and not greater
than one hundred twenty percent (120%) of the amount for such month stated in the most recent rolling forecast unless Oasmia agrees
to an amount outside of such limits, such agreement not to be unreasonably withheld Promptly after receipt of Abbott’s firm
purchase orders for Product, and in no case later than ten (10) days after, Oasmia shall confirm to Abbott its acceptance of the
purchase order, delivery date, and quantity of Product ordered by Abbott. 

 

6.3           “Minimum
PO Lead Time” shall mean the minimum number of days prior to requested Product delivery that purchase orders shall be placed
as mutually agreed to by the Parties, and shall initially be ninety (90) days. The Parties may change the Minimum PO Lead Time
from time to time by mutual agreement and evidenced in writing.

 

6.4           On
or before the fifteenth (15th) day of each month, Abbott shall provide Oasmia with a forecast of its expected purchases over the
next twelve (12) months. The forecast for those months that are within the Minimum PO Lead Time shall be consistent with the purchase
orders already placed by Abbott. The forecast for those months outside the Minimum PO Lead Time shall consist of Abbott’s
best estimate forecast of its requirements of Products and will not be binding. Generally, deliveries for a given month will be
expected during the first week of the month, but the actual expected delivery date for any given month will be as stated in Abbott’s
firm purchase order. So as an example, if the Minimum PO Lead Time remains at 90 days, a forecast submitted on May 15 would reflect
already-placed purchase orders for delivery on June 1, July 1, and August 1, and the quantity shown for September 1 delivery would
be supported by a purchase order submitted shortly thereafter, but in no case later than June 3 (i.e. 90 days prior to September
1).”

 

11.         Clause
7.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Oasmia
shall manufacture and deliver Product to Abbott in such quantities as are stated in Abbott’s firm purchase orders. Actual
delivery dates may be up to five (5) days prior to, but no later than, the ordered delivery date. All shipments will be made using
a validated shipping container and method, ensuring temperature requirements are maintained and monitored using a temperature
monitoring device. The shipping container must be labelled with storage requirements.”

 

    	10

    	 

    

  

12.         Clause
7.3 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“All
Products delivered by Oasmia shall be FCA Uppsala Sweden per Incoterms 2010. Title shall pass to Abbott at this point and Abbott
will be the importer of record.”

 

13.         Clause
7.4 of the Agreement is hereby amended by adding the following sentence to the end of the Clause:

 

“Oasmia
will deliver Product to Abbott with a remaining shelf life no less than six (6) months less than the full shelf life for such
Product as accepted by the relevant Regulatory Authorities for such Product, unless Abbott agrees in writing to a shorter remaining
shelf-life.”

 

14.         Clause
8.9 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“The
transfer price paid by Abbott to a Second Source Manufacturer in accordance with the terms and conditions hereunder shall serve
as the Supply Price for the purposes of calculating Royalties as described in Appendix 1.25.”

 

15.         Clause
8 of the Agreement is hereby amended by adding the following as Clause 8.10:

 

“8.10         Within
ninety (90) days of the First Amendment Effective Date, Oasmia shall prepare a Paccal Vet manufacturing site transfer plan for
a third party manufacturer to act as a Second Source Manufacturer if needed to support commercial Paccal Vet product supply until
full transfer of Paccal Vet manufacturing out of Oasmia facility (the “Paccal Vet Second Source Manufacturer Plan”).
The Paccal Vet Second Source Manufacturer Plan shall be approved by JDC no later than April 30, 2013.”

 

16.         The
second sentence of Clause 9.1 is hereby deleted in its entirety.

 

17.         Clause
10.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Oasmia
will supply a reasonable quantity of samples of the Product to Abbott or its Affiliates for use and for post marketing studies.
The reasonable quantity shall be agreed by the Parties in good faith. These quantities shall be planned, and be part of the Rolling
Forecast volumes. These samples will be provided free of charge, FCA Uppsala Sweden Incoterms 2010. Title shall pass to Abbott
at this point and Abbott will be the importer of record.”

 

    	11

    	 

    

  

18.         Clause
10.2 of the Agreement is hereby deleted in its entirety.

 

19.         Clause
11.1(a) of the Agreement is hereby amended by adding the following to the end of the Clause: “, including but not limited
to the EC Directive”.

 

20.         Clause
11.1(c) of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“shall
have an approved shelf life of at least twenty-four (24) months from the date of manufacture; Oasmia shall use commercially reasonable
efforts to extend the shelf life from date of manufacture beyond twenty-four (24) months from the date of manufacture;”

 

21.         The
third sentence of the second paragraph of Clause 11.5 is hereby deleted in its entirety and replaced with the following:

 

“If
Oasmia’s test results reasonably confirm the Product as Non-Conforming Product, the Parties shall mutually agree on the
method of disposing of the Non-Conforming Product, in every case at Oasmia’s expense, and Oasmia shall, at Abbott’s
option, either make a replacement delivery of conforming Products within thirty (30) days from receipt of Abbott’s notice
or reimburse Abbott for any payments made for such Non-Conforming Products.”

 

22.         Clause
11 of the Agreement is hereby amended by adding the following as Clause 11.8:

 

11.8         Oasmia
shall take all commercially reasonable actions, including the engagement of an on-going external consultant and/or a full time
employee as needed, to secure Conditional Approval for Paccal Vet no later than October 31, 2013 through execution of the a comprehensive
action plan to prepare for a successful FDA prior approval inspection and cGMP audit for the Product (with the plan and timeline
to be reviewed and approved by the JDC no later than March 31, 2013 and the jointly developed action plan to respond to FDA’s
CMC technical section deficiency letter.”

 

23.         Clauses
12 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“12.1         Abbott
shall use commercially reasonable efforts to proceed with marketing and sales of a Product in the Field in each country in the
Territory after Oasmia obtains the Marketing Authorization for such Product in such country in accordance with Clause 12.2 below.

 

12.2         Abbott
shall use its commercially reasonable efforts to launch a Product within ten (10) months of receipt of notice and documentation
from Oasmia that it has obtained the Marketing Authorization for such Product in a country in the Territory and shall use its
commercially reasonable efforts to market, offer for sale and sell such Product in the Field in such country for the remainder
of the Term, unless Abbott determines that market or business conditions have changed such that launching or continuing to market
the Product in such country is no longer commercially attractive for Abbott. If Abbott so determines, it shall so inform Oasmia
and the Parties shall promptly meet to discuss in good faith the commercially reasonable actions that the Parties shall take with
respect to such country that Abbott has determined not to launch in or continue to market the Product.

 

    	12

    	 

    

  

12.3         Abbott
shall be solely responsible for the marketing costs in the Territory, except costs related to post-marketing studies. If post-marketing
studies are required by the relevant regulatory authorities to maintain Marketing Authorization, such costs shall be the sole
responsibility of Oasmia.

 

12.4         Oasmia
shall make available to Abbott within ninety (90) days of the Date of Agreement all data, results, information, development and
documentation of Oasmia, including without limitation raw data that is a part of Oasmia Proprietary Rights and necessary in connection
with Abbott’s performance and exploitation of rights under this Agreement as exists at the Date of Agreement. Each Party
agrees to share with the other all pre-clinical, Chemistry, Manufacturing and Control (“CMC”) and clinical data and
results involving Product, including without limitation raw data, which it has developed, develops, or obtains from a third party
(including each Party’s licensees and/or distributors) during the Term. Such sharing by each Party shall take place as soon
as reasonably practicable after such data or results become available.

 

12.5         Neither
Party shall publish or present the results of any research, development or any other information relating to a Product (“Proposed
Disclosure”) without submitting the Proposed Disclosure to the JDC for the sole purpose of providing comments on the Proposed
Disclosure and to ascertain whether any patentable subject matter or confidential information is contained within the Proposed
Disclosure to enable the Parties to take any necessary steps to control the dissemination of such patentable subject matter or
confidential information. The Party desiring to publish or present such Proposed Disclosure shall submit such Proposed Disclosure
for review to the JDC sufficiently in advance of the proposed date of the publication or presentation of the Proposed Disclosure
so that, where reasonable under the circumstances, the JDC has at least forty-five (45) days to review the Proposed Disclosure
(“Review Period”). The JDC shall use its best efforts to expedite the review of any Proposed Disclosure that is time-sensitive.
Abbott shall be entitled to use the Proposed Disclosure for the purposes of creating marketing and promotional material for use
by Abbott in the Territory. Notwithstanding anything in this Clause 12.5 to the contrary, neither Party shall be required to seek
approval of the other Party for the publication or presentation of the results of research, development or any other information
relating to a Product that has been submitted to any third party for publication on or prior to the First Amendment Effective
Date; provided, however, that Oasmia shall provide Abbott with copies of all such publications (or pending publications)
within forty-five (45) days after the First Amendment Effective Date. The Parties shall maintain the confidentiality of the Proposed
Disclosure in accordance with Clause 19 until the later of completion of the Review Period or, in the event a Party desires to
secure patent or other proprietary protection of information contained within the Proposed Disclosure, thirty (30) days after
expiration of the Review Period.”

 

    	13

    	 

    

  

24.         Clause
13.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“Neither
Abbott nor Oasmia shall make or procure or permit the making of any announcement or statement to the public with respect to this
Agreement without the prior consent of the other Party, which consent shall not be unreasonably withheld, subject to any applicable
regulatory and/or stock exchange requirements. Oasmia will provide Abbott with a minimum of five (5) business days for review
and approval of any press releases or public statements. The wording and the timing of any press release or of any other announcement
and/or statement to the public shall have to be agreed upon in advance between the Parties.”

 

25.         Clause
14.1 of the Agreement is hereby amended by deleting the words “Date of Agreement” in the last line of such Clause
with “the First Amendment Effective Date”.

 

26.         The
first sentence of Clause 17.1 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“This
Agreement shall become effective upon the Date of Agreement and, except as hereinafter provided for in this Clause 17 or stipulated
for elsewhere in this Agreement, shall continue in effect thirty (30) years from the date Oasmia achieves the first milestone
set forth in Clause 5 or expiration of all Oasmia Patent Rights, whichever is earlier (hereinafter referred to as “Initial
Period”).”

 

27.         Clause
17.8 of the Agreement is hereby deleted in its entirety and replaced with the following:

 

“In
the event of termination of this Agreement by Abbott for Oasmia’s insolvency or other enumerated circumstance pursuant to
Clause 17.3, (i) Abbott shall be exclusively granted all legal rights in the Territory in the Field to the Conditional Approvals,
Marketing Authorizations, Registration Dossiers, Specifications and Development Plans, including the right to sublicense, to manufacture,
have manufactured, use, import, offer for sale, have sold and/or sell, and (ii) Abbott shall be non-exclusively granted all legal
rights in the Territory in the Field to the Oasmia Proprietary Rights, Improvements, the Oasmia Trademark and anything else necessary
to enable Abbott to continue Development and commercialization of the Products in the Field in the Territory, including the right
to sublicense, to manufacture, have manufactured, use, import, offer for sale, have sold and/or sell . In the event of termination
of this Agreement by Abbott pursuant to Clause 17.2 hereof as a consequence of Oasmia having been determined in accordance
with the provisions of this Agreement to have committed a material breach of the terms or conditions of this Agreement (A) Abbott
shall be granted the rights granted in subclause (ii) of the immediately preceding sentence and shall also be granted the
rights set forth in subclause (i) of the immediately preceding sentence, except that all such rights set forth in such subclause (i)
of the immediately preceding sentence shall be on a non-exclusive rather than an exclusive basis, and (B) Oasmia shall refund
to Abbott any milestone payments paid by Abbott hereunder as of the date of such termination. In the event of termination of this
Agreement by Oasmia (A) pursuant to Clause 17.2 hereof as a consequence of Abbott having been determined in accordance
with the provisions of this Agreement to have committed a material breach of the terms or conditions of this Agreement, or (B) for
Abbott’s insolvency or other enumerated circumstance pursuant to Clause 17.3, Oasmia shall have no obligation to refund
to Abbott any milestone payments paid by Abbott hereunder as of the date of such termination.”

 

    	14

    	 

    

  

28.         Clause
17.9 is hereby amended by removing the reference to Clause 5.3.

 

29.         New
Clause 24.2 is hereby added:

 

“24.2         In
the event that Abbott, in good faith, believes that Oasmia’s material breach of this Agreement is wilful and in bad faith
and in order to deprive Abbott of the economic benefits of this Agreement, in addition to, and not in lieu of, any other rights
or remedies that Abbott may be entitled to pursuant to Clause 24.1 above, Abbott shall have the right to seek equitable relief,
including the issuance of a temporary or permanent injunction, by any court of competent jurisdiction residing in the State of
New York, Manhattan County, and that the prevailing party in any such judicial proceeding shall receive from the other party all
reasonable attorneys fees and disbursements incurred in connection with such proceeding(s), as well as any reasonable legal fees
and disbursements incurred by the prevailing party in enforcing and pursuing its right to receive all such reasonable legal fees
and disbursements pursuant to this Clause 24.2.”

 

30.         Clause
25 is hereby amended by adding the following as Clauses 25.1 and 25.2 and renumbering the balance of Clause 25 accordingly:

 

“25.1         Oasmia
acknowledges and agrees that it shall be solely responsible for: (a) obtaining all appropriate licenses necessary to make, have
made, use, import, sell or offer for sale the Product in the Field in the Territory during the Term; (b) paying consideration,
including, royalties, to third parties for any intellectual property covering the Product; and (c) satisfying any other license
obligations of Oasmia to third parties to make, have made, use, import, sell or offer for sale the Product.

 

25.2         The
Parties agree that the Oasmia Patent Rights set forth in Appendix 1.18 relate to the Product and are owned by or licensed to Oasmia
as of the Date of the Agreement.  Oasmia shall have responsibility, at its sole cost and expense, for obtaining and maintaining
the Oasmia Patent Rights listed in Appendix 1.18 and in any other countries the JDC agrees to seek Marketing Authorization for. 
For purposes of the foregoing, such obtaining and maintaining shall include, without limitation, prosecution before the relevant
patent offices of pending patent applications, reexaminations, post-grant review, inter partes review, oppositions and interferences,
and payment of applicable annuity and maintenance fees.  Oasmia shall use commercially reasonable efforts to obtain any available
extensions of exclusivity beyond the full term expiry date of any of the Oasmia Patent Rights in the Territory, such as Patent
Term Adjustment and Extension in the United States Patent Office and Supplementary Protection Certificates in the European Patent
Office.  If Oasmia elects to cease obtaining or maintaining any Oasmia Patent Rights in the Territory, Oasmia shall give
prompt written notice to Abbott, and Abbott may, at its cost and expense, assume responsibility for obtaining and maintaining
such Oasmia Patent Rights.  The assumption by Abbott of the obligation for maintaining the Oasmia Patent Rights shall not,
in any way, alter or affect the obligation of Oasmia to indemnify Abbott pursuant to Clause 18.”

 

    	15

    	 

    

  

31.         New
Clause 25.5 (after the renumbering described above) is hereby amended by adding the following after its second sentence:

 

“Abbott
acknowledges the validity of the title of Oasmia to any trademark (including Oasmia Trademarks), service mark, logo, design mark,
trade name, or other trade dress of Oasmia (or licensed for use by Oasmia) (“Oasmia Mark”) that may be used
in conjunction with the Product. No right, title or interest in and to any Oasmia Mark is granted by this Agreement. Abbott shall
cease the use of any Oasmia Mark upon request by Oasmia. Any goodwill associated with the use of such Oasmia Mark shall be the
exclusive property, and inure to the benefit, of Oasmia or its licensors. Abbott shall not use any Oasmia Mark in any publicity,
advertising or announcement or for any other commercial purpose without the prior written approval of Oasmia, for each such use.
Abbott agrees that it shall not at any time, either during the Term or thereafter, do anything that would adversely affect Oasmia
or its Affiliates’ rights in and to any Oasmia Mark in any country or territory worldwide, nor assist anyone else in doing
so, including the following: (a) apply for registration of any Oasmia Mark, or any mark confusingly similar thereto (in Oasmia’s
sole opinion); (b) apply for registration of any domain name that incorporates any Oasmia Mark or any mark confusingly similar
thereto (in Oasmia’s sole opinion); (c) subject to the limited rights granted to it in this Clause 25, use or authorize
the use of any trademark, trade name or other designation confusingly similar to any Oasmia Mark (in Oasmia’s sole opinion);
or (d) contest the validity, strength, or fame of any Oasmia Mark.”

 

32.         New
Clause 25.6 (after the renumbering described above) is hereby amended by adding the following after its second sentence:

 

“Oasmia
acknowledges the validity of the title of Abbott to any trademark (including Abbott Trademarks), service mark, logo, design mark,
trade name, or other trade dress of Abbott (or licensed for use by Abbott) (“Abbott Mark”) that may be used
in conjunction with the Product. No right, title or interest in and to any Abbott Mark is granted by this Agreement. In the event
that the Specifications require Oasmia to use an Abbott Mark or mark Product with one or more Abbott patent numbers, then Oasmia
shall use such Abbott Mark and Abbott patent number only with respect to the Product manufactured for delivery to Abbott hereunder.
Oasmia shall cease the use of any Abbott Mark upon request by Abbott. Any goodwill associated with the use of such Abbott Mark
shall be the exclusive property, and inure to the benefit, of Abbott or its licensors. Oasmia shall not use any Abbott Mark in
any publicity, advertising or announcement or for any other commercial purpose without the prior written approval of Abbott, for
each such use. Oasmia agrees that it shall not at any time, either during the Term or thereafter, do anything that would adversely
affect Abbott or its Affiliates’ rights in and to any Abbott Mark in any country or territory worldwide, nor assist anyone
else in doing so, including the following: (a) apply for registration of any Abbott Mark, or any mark confusingly similar thereto
(in Abbott’s sole opinion); (b) apply for registration of any domain name that incorporates any Abbott Mark or any mark
confusingly similar thereto (in Abbott’s sole opinion); (c) subject to the limited rights granted to it in this Section
25, use or authorize the use of any trademark, trade name or other designation confusingly similar to any Abbott Mark (in Abbott’s
sole opinion); or (d) contest the validity, strength, or fame of any Abbott Mark.”

 

    	16

    	 

    

  

33.         Clause
31.1 is hereby amended by adding the following after the first sentence:

 

“Words
in the singular shall be deemed to include the plural and vice versa and words of one gender shall be deemed to include the other
genders as the context requires. The terms “hereof,” “herein,” and “herewith” and words of
similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole (including all of the Appendixes
hereto) and not to any particular provision of this Agreement. Article, Clause, and Appendix references are to the Articles, Clause,
and Appendix to this Agreement unless otherwise specified. The word “including” and words of similar import when used
in this Agreement shall mean “including, without limitation,” unless the context otherwise requires or unless otherwise
specified. The word “or” shall not be exclusive. Unless otherwise specified in a particular case, the word “days”
refers to calendar days.”

 

34.         Appendix
1.11 is hereby deleted in its entirety.

 

35.         Appendix
1.18 is hereby deleted in its entirety and replaced with Exhibit A attached hereto.

 

36.         Appendix
1.21 is hereby deleted in its entirety and replaced with Exhibit B attached hereto.

 

37.         Appendix
1.24 is hereby deleted in its entirety and replaced with Exhibit C attached hereto.

 

38.         Appendix
1.25 is hereby deleted in its entirety and replaced with Exhibit D attached hereto.

 

39.         Appendix
14.1 is hereby deleted in its entirety and replaced with Exhibit E attached hereto.

 

40.         Miscellaneous.

 

A.           All
terms and conditions set forth in the Agreement that are not amended hereby shall remain in full force and effect.

 

B.           This
First Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which will constitute one
and the same instrument.

 

C.           This
First Amendment is the product of both of the Parties hereto, and together with the Agreement constitutes the entire agreement
between such Parties pertaining to the subject matter hereof, and merges all prior negotiations and drafts of the Parties with
regard to the transactions contemplated herein.

 

D.           From
the date hereof, any reference to the Agreement shall be deemed to refer to the Original Agreement as amended by this First Amendment.

 

[Signature
Page to Follow]

 

    	17

    	 

    

  

IN
WITNESS WHEREOF, the Parties, through their authorized officers, have executed this First Amendment as of the First Amendment
Effective Date.

 

	ABBOTT LABORATORIES	 	OASMIA PHARMACEUTICAL
    AB
	 	 	 
	 	 	 
	 	 	 
	Name:	 	 	Name:	 
	 	 	 	 	 
	Title:	 	 	Title:	 
	 	 	 	 	 
	Dated:	 	 	Dated:	 

 

    	18

    	 

    

  

Execution
Copy

 

EXHIBIT
A

 

APPENDIX
1.18

 

Oasmia Patent
Rights

 

Part 1 – Paccal Vet

 

	Taxol containing compositions	 	 	 	 
	US 10/098,873	 	U.S. Patent No.  6,642,271	 	Granted
	EP 02701856.3	 	European Patent No. 1 387 844	 	Granted
	EP 07106715.1	 	Divisional European Patent 1826198	 	Granted
	EP 09167175.0	 	Divisional European Patent Application	 	Awaiting grant
	AU 2002-235085	 	Australian Patent No. 2002235085	 	Granted
	JP 2002-589484	 	Japanese Patent No. 4147114	 	Granted
	CA 2,445,478	 	Canadian Patent No. 2445478	 	Granted
	ID W00200302232	 	Indonesian Patent No. ID 0 018 944	 	Granted
	MY PI 20034101	 	Malaysian Patent No. MY-136047-A	 	Granted
	 	 	 	 	 
	Anticancer compositions	 	 	 	 
	US 10/295,139	 	U.S. Patent No. 7,030,158	 	Granted
	EP 02783947.1	 	European Patent Application	 	Awaiting grant
	CN 02829608.7	 	Chinese Patent No. ZL02829608.7	 	Granted
	HK 06100168.0	 	Hong Kong Patent No. HK1080447	 	Granted
	 	 	 	 	 
	Water insoluble	 	 	 	 
	EA 200802350	 	Eurasian Patent No. 015247	 	Granted
	AU 2008339099	 	Australian Patent Application	 	Pending
	Brasilian Patent Application	 	Brasilian Patent Application	 	Pending
	Canadian Patent Application	 	Canadian Patent Application	 	Pending
	Chinese Patent Application	 	Chinese Patent Application	 	Pending
	EP 08861526.5	 	European Patent Application	 	Pending
	IN 2633/KOLNP/2010	 	Indian Patent Application	 	Pending
	Japanese Patent Application	 	Japanese Patent Application	 	Pending
	KR 10-2010-7015610	 	South Korean Patent Application	 	Pending
	MX/A/2010/006914	 	Mexican Patent Application	 	Pending
	MY PI 2010002787	 	Malaysian Patent Application	 	Pending
	New Zealand Patent Application	 	New Zealand Patent Application	 	Pending
	US 12/809,252	 	U.S. Patent Application	 	Pending
	ZA 2010/04685	 	South African Patent No. 2010/04685	 	Granted

 

    	 

    	 

    

 

 

 

EXHIBIT
A

 

APPENDIX
1.18

 

Oasmia Patent
Rights

 

Part 2 – Doxophos Vet

 

	Water soluble	 	 	 	 
	AU 2008339100	 	Australian Patent Application	 	Pending
	Brasilian Patent Application	 	Brasilian Patent Application	 	Pending
	Canadian Patent Application	 	Canadian Patent Application	 	Pending
	Chinese Patent Application	 	Chinese Patent Application	 	Pending
	EA 201070625	 	Eurasian Patent Application	 	Pending
	EP 08861217.1	 	European Patent Application	 	Pending
	IN 2367/KOLNP/2010	 	Indian Patent Application	 	Pending
	Japanese Patent Application	 	Japanese Patent Application	 	Pending
	KR 10-210-7015632	 	South Korean Patent Application	 	Pending
	MX/A/2010/006907	 	Mexican Patent Application	 	Pending
	MY PI 2010002786	 	Malaysian Patent Application	 	Pending
	New Zealand Patent Application	 	New Zealand Patent Application	 	Pending
	US 12/809,259	 	U.S. Patent Application	 	Pending
	ZA 2010/04652	 	South African Patent No. 2010/04652	 	Granted

 

    	 

    	 

    

  

EXHIBIT
B

 

APPENDIX
1.21

 

Products

 

Paccal Vet:

 

Paccal Vet
is a preparation consisting of the Compounds and XR17 (including all salts of XR17) for the treatment of cancer with the active
pharmaceutical ingredient paclitaxel. XR17 is a proprietary mixture of the sodium salts of N-all-trans-retinoyl cysteic acid methyl
ester and N-13-cis-retinoyl cysteic acid methyl ester. The product can be in the form of a water soluble lyophilisate or as a
solution for injection. The Compounds can be of natural, semi-synthetic or synthetic origin.

 

Product shall
be Paccal Vet in final sellable form, furnished hereunder in the packaging and with the materials set forth below at no additional
cost:

 

1.          Vial
Glass type I, with rubber stopper and aluminum cap containing 60mg of Paccal Vet

2.          Box carton;

3.          Label;

4.          Client information sheet;

5.          Package insert; and

6.          Material Safety Data Sheet.

 

Doxophos
Vet:

 

Doxophos Vet
is a preparation consisting of the Compounds and XR17 (including all salts of XR17) for the treatment of cancer with the active
pharmaceutical ingredient doxorubicin. XR17 is a proprietary mixture of the sodium salts of N-all-trans-retinoyl cysteic acid
methyl ester and N-13-cis-retinoyl cysteic acid methyl ester. The product can be in the form of a water soluble lyophilisate or
as a solution for injection. The Compounds can be of natural, semi-synthetic or synthetic origin.

 

Product shall
be Doxophos Vet in final sellable form, furnished hereunder in the packaging and with the materials set forth below at no additional
cost:

 

1.          Vial
Glass type I, with rubber stopper and aluminum cap containing 50mg of Doxophos Vet

2.          Box carton;

3.          Label;

4.          Client information sheet;

5.          Package insert; and

6.          Material Safety Data Sheet.

 

    	 

    	 

    

  

EXHIBIT
C

 

APPENDIX
1.24

 

Manufacturing
Specifications

 

See attached

 

    	 

    	 

    

  

EXHIBIT
D

 

APPENDIX
1.25

 

Supply Price
and Royalty

 

Definitions

 

“The
Supply Price” for each Product shall be one hundred and five percent (105%) of Oasmia’s All-In Cost of Goods for
such Product.

 

“All-In
Cost-of-Goods” shall mean all direct out-of-pocket costs and Allocable Overhead incurred in the manufacture, packaging,
storage and quality assurance release of the Product.

 

“Allocable
Overhead” shall mean with respect to Oasmia’s manufacture, packaging, storage and quality assurance release of
the Product, costs directly related to such activities and incremental costs actually incurred by Oasmia or for its account, including
but not limited to, those which are attributable to Oasmia’s supervisory services, quality control, occupancy costs, financial
costs, depreciations and its payroll, information systems, delivery systems, or purchasing functions and which are allocated to
company departments based on space occupied or headcount or other activity-based method consistently applied by Oasmia. Allocable
Overhead shall not include any costs attributable to general corporate activities including executive management, investor relations,
business development and legal affairs.

 

Supply Price

 

The Supply
Price will be set once per year by Oasmia based on its projected All-In Cost of Goods for Product for the upcoming calendar year
(January 1 to December 31) and will be effective for all orders scheduled for delivery in that calendar year. The Supply Price
shall be set in Euros, and Abbott will pay Oasmia in such currency. For calculating the Supply Price, Oasmia shall convert components
of the Supply Price in non-Euro currencies to their Euro equivalent using Oasmia’s standard methodology, which shall be
according to IFRS. Oasmia shall inform Abbott of the Supply Price for each calendar year no later than August 15 of the preceding
year.

 

Royalty

 

In consideration
of the rights granted to Abbott and set forth in this Agreement and for Oasmia’s compliance with the terms and conditions
hereunder, Abbott shall pay royalties to Oasmia as set forth below (“Royalties”).

 

			In each calendar
                                         year, Royalties shall equal the greater of: (I) eighteen percent (18%) of Net Sales,
                                         or

 

(II)
(a) thirty-four percent (34%) of Net Sales, up to a maximum of Forty Million Dollars ($40,000,000) of Net Sales, plus

 

    	 

    	 

    

  

			(b) forty percent
                                         (40%) of the amount Net Sales exceeds Forty Million Dollars ($40,000,000) up to a maximum
                                         of Fifty-Five Million Dollars ($55,000,000) of Net Sales, plus

 

(c)
fifty percent (50%) of the amount Net Sales exceeds Fifty-Five Million Dollars ($55,000,000), minus

 

(d)
the Supply Price paid for the Products sold to achieve the full amount of Net Sales for such calendar year.

 

For example,
if the amount of Net Sales in a given calendar year is $60 million, and the total Supply Price paid for the Products sold that
year is $10 million, the Royalty for such year would be calculated as follows:

 

First
Tier:              34% x $40 million = $13.6 million, plus

 

Second
Tier:        40% x ($55 million - $40 million) = $6.0 million, plus

 

Third
Tier:            50% x ($60 million - $55 million) = $2.5 million,
minus

 

Supply
Price:        $10.0 million

 

Total
Royalty:      $12.1 million

 

For
calculating the amount of Royalty due, Abbott shall convert the Supply Price and all Net Sales occurring in non-US currencies
to their US Dollar equivalent using Abbott’s standard methodology, which shall be according to US GAAP.

 

Following the
commencement of Product sale in any country in the Territory, Abbott shall, within thirty (30) days of the end of every Calendar
Quarter pay Royalties due to Oasmia and provide Oasmia with an accounting of the Royalties calculation for such Calendar Quarter.
In addition, Abbott shall, within ten (10) days of the end of every calendar month provide Oasmia with an estimate of Net Sales
for such calendar month.

 

Taxes

 

All sums payable
under this Agreement are exclusive of any Value Added Tax or any other sales tax or duties, which where applicable, shall be payable
by the payer in addition to any sum in respect of which they are calculated.

 

Interest

 

All payments
due hereunder that are not paid when due and payable shall bear interest on annual rate equal to LIBOR plus two percent (2%) from
the due date until paid.

 

    	 

    	 

    

  

Abbott Records
and Control

 

Abbott (together
with its Affiliates, agents, representatives, sub-distributors, co-marketing partners and successors) shall keep and maintain
complete and accurate records of the sales and all necessary data for calculation of the Net Sales for the Product for each year
and shall retain such records for a period of three (3) years thereafter. Oasmia shall have the right to nominate a firm of independent
certified public accountants acceptable to Abbott to inspect such records for the purpose of verifying, at Oasmia’s expense
and during reasonable business hours, Net Sales, provided that this right may not be exercised more than once in any calendar
year, and provided further that such accounting firm shall be first made subject to confidentiality obligations not more burdensome
than those to which the Parties are subject to under this Agreement. If Abbott is required to reimburse Oasmia for an underpayment
(in any amount) it shall do so within thirty (30) days of its receipt of notice from Oasmia of the result of the accountants’
audit. In the event that the accountants’ audit find that an underpayment of five per cent (5%) or more has been made by
Abbott, Abbott shall reimburse Oasmia the cost of the audit (within thirty (30) days of its receipt of notice of the results of
the audit).

 

Oasmia Records
and Control

 

Oasmia shall
maintain, and require its Affiliates and any third party manufacturers to maintain, accurate records of All-In Cost-of-Goods and
Allocable Overhead of the Products as well as relevant invoicing or other documentation relating thereto. Upon reasonable prior
written notice from Abbott, Oasmia shall allow such records to be made open to audit by Abbott or on Abbott’s behalf by
an independent certified public accountant of Abbott’s selection, to verify Oasmia’s All-In Cost-of-Goods and Allocable
Overhead of the Products and reasonableness of any changes to such costs that are requested by Oasmia. Such accountant, if any,
shall be first made subject to confidentiality obligations not more burdensome than those to which Abbott and Oasmia are subject
to under this Agreement. Oasmia’s records which are the object of this audit clause shall be maintained and be made available
for audit for a period of at least three (3) years from the end of each then current year. In the event that such audit finds
that an overcharge of five percent (5%) or more has been made by Oasmia, Oasmia shall reimburse Abbott the cost of the audit (within
thirty (30) days of its receipt of notice of the results of the audit).

 

    	 

    	 

    

  

EXHIBIT
E

 

APPENDIX
14.1

 

Pharmacovigilance

 

To be completed as agreed to by
the JDC prior to launch of Product within any country in the Territory.Exhibit 10.9

 

DEVELOPMENT,
SUPPLY AND EXCLUSIVE LICENSE

AGREEMENT

 

This Development, Supply and Exclusive License
Agreement is made between

 

Oasmia Pharmaceutical AB (“Licensor”)

a corporation organized under the laws of
Sweden

and having its principal office at

Vallongatan 1, 752 28 Uppsala, Sweden

and

 

Nippon Zenyaku Kogyo Co. Ltd (“Licensee”)

a corporation organized under the laws of
Japan

and having its principal office at

1-1 Tairanoue Sasagawa, Asaka-machi,

Kooriyama City, Fukushima Prefecture

963-0196 Japan

 

and takes effect as of April 21, 2010 (the
“Effective Date”).

 

WHEREAS

 

		-	Licensor has certain worldwide rights to Licensed Technology (hereinafter defined) to a veterinary pharmaceutical product (hereinafter
defined).

 

		-	Licensee is a company specializing in marketing and distribution of veterinary pharmaceutical products and has the competencies
and capabilities to develop, register, market and distribute the Product in the Territory (hereinafter defined).

 

		-	Licensor is desirous of granting to Licensee, and Licensee is desirous of accepting from Licensor, the exclusive rights to
sell the Product in the Territory using the Licensed Technology.

 

		-	Licensor is desirous of supplying Licensee's requirements of the Product and Licensee is desirous of purchasing the same from
Licensor.

 

    	1 (42)

    	 

    

 

		1.	DEFINITIONS

 

		1.1	“Affiliate” shall mean any entity that directly (or indirectly through one or
more intermediaries) controls, is controlled by, or is under common control with a party, and the term “control” means
control of (i) more than half of the voting power or issued share capital, or (ii) the control directly or indirectly to direct
or cause direction of the management and policies of an entity; and the terms “controls” and “controlled”
shall be construed accordingly;

 

		1.2	“Agreed Quality” shall have the meaning given in Clause 17.1;

 

		1.3	“Agreement” shall mean this Development, Supply and Exclusive License Agreement;

 

		1.4	“Claim” shall mean any claim, action, demand, proceeding, complaint or
other similar action (including, but not limited to, any such claim, action, demand, proceeding, complaint or other similar action
by a third party);

 

		1.5	“Clinical Trial” shall have the meaning given in Clause 3.1;

 

		1.6	“Competent Authorities” shall mean any and all competent and regulatory authorities
in the Territory: (i) that are responsible for the regulation of veterinary medicinal products intended for human use and responsible
for granting any Marketing Authorisation, (ii) all local Veterinary Medicinal Product Agencies; and (iii) all pricing and reimbursement
authorities;

 

		1.7	“Confidential Information” shall mean in relation to a party any secret or proprietary
information (whether written or oral and in whatever medium) relating to a party’s business or of the business of their Affiliates,
including Intellectual Property Rights, the Trademark, Know-how, the Improvements, the Product and related developments, other
products, substances, customer lists, pricing policies, employment records and policies, operational methods, marketing and strategy
plans and policies, product development techniques or plans, regulatory data, data, regulatory applications and dealings, methods
of manufacture, technical processes, designs and design projects, inventions and research programmes, trade secrets and other business
affairs, and any other information of a confidential nature of the party or of its Affiliates; 

 

		1.8	“CT Product” shall have the meaning given in Clause 3.2;

 

		1.9	“Data or Market Exclusivity” shall mean any data protection, market exclusivity
or any similar protection granted to the Product according to the applicable rules and regulations in the Territory;

 

		1.10	“Data Protection Laws” shall mean the data privacy and data protection laws
applicable to the Personal Data and activities in relation to such Personal Data;

 

		1.11	“Data Provider” shall have the meaning given in Clause 7.1;

 

		1.12	“Data Recipients” shall have the meaning given in Clause 7.1;

 

    	2 (42)

    	 

    

 

		1.13	“Detailed Manufacturing Documentation” shall mean all of Licensor’s standard
operating procedures for the manufacture of the Product from time to time in place;

 

		1.14	“Effective Date” shall mean the signing date of this Agreement as first above
written;

 

		1.15	“Field” shall mean veterinary therapy.

 

		1.16	“Finished Product” shall mean the Product packaged, labelled and released according
to the specifications approved by Competent Authorities for distribution and sale in the Territory;

 

		1.17	“Fiscal Year” shall mean a period from April 1 in one Year to March 31 in the
following Year;

 

		1.18	“GMP” shall mean current Good Manufacturing Practice for veterinary medicinal
products as defined in all applicable legislation and guidelines; 

 

		1.19	“Improvements” shall mean (a) any change in, or development, improvement or
derivative of, or modification to the Licensed Technology or the method of manufacture, processing or use in relation to or application
of the Licensed Technology (whether patentable or not), including improvements defined as aforesaid which (i) embody, use or are
improvements to or derivatives of Licensed Technology; or (ii) which would infringe any patent or employ any Know-how included
in Licensed Technology; or (iii) otherwise relate to the Product; and (b) improvements in or additions to Know-how relating to
the Product. “Improvements” shall always exclude data and Information falling within the definition of Regulatory
and Clinical Data;

 

		1.20	“Indemnitee” shall have the meaning given in Clause 22.3.1

 

		1.21	“Indemnitor” shall have the meaning given in Clause 22.3.1

 

		1.22	“Information” means any information, communications or data, in any form, including
oral, written, graphic, electro-magnetic, in machine readable form, computerised, or otherwise stored in any media;

 

		1.23	“Intellectual Property” shall mean all intellectual property including all patents,
trade marks, service marks, registered designs, utility models, design right, database rights, copyright, trade secrets and other
confidential information, know-how, and all other intellectual and industrial property and rights of a similar or corresponding
nature in any part of the world, whether registered or not or capable of registration or not and including the right to apply for
and all applications for any of the foregoing rights, right to claim priority, the right to sue for past infringements and common
law or equitable remedies in respect of any of the foregoing rights, and any renewals, extensions or restorations, and divisional,
continuation and reissued applications of the foregoing rights (and “Intellectual Property Rights” means rights,
title and interest including all moral rights in such Intellectual Property);

 

    	3 (42)

    	 

    

 

		1.24	“Know-how” shall mean any and all relevant Information, data and/or know-how,
unpatented formulae, processes, trade secrets and technologies, whether or not patentable from time to time during the Term owned
or controlled by the relevant party, including that relating to: (i) the toxicology, pharmacology, and use of the Product; (ii)
production or manufacturing, synthesis, preparation, recovery and purification processes and techniques, control methods and assays,
chemical data, toxicological data and pharmacological techniques relating to the Product or Finished Product; or (iii) the promotion,
marketing, sale and distribution of the Finished Product (including customers) in the Territory;

 

		1.25	“Licensed Technology” shall mean collectively the Know-how and the Regulatory
and Clinical Data owned or controlled by Licensor and Licensor's Patents, in each case to the extent that they relate to the Field;

 

		1.26	“Licensor's Patents” shall mean Patents Rights in the Territory shown in Appendix
II that are owned or controlled by Licensor and that relate to the Product, including its uses and processes for manufacture;

 

		1.27	“Losses” shall mean losses of whatsoever nature, including damages, payments,
penalties, interest, fines and compensation, howsoever they might arise, whether as a result of a tort (including negligence),
breach of contract, breach of statutory duty or misrepresentation and shall include all reasonable professional fees and expenses;

 

		1.28	“Marketing Authorisation” shall mean any and all marketing and other authorisations
and approvals for uses in the Field by Competent Authorities or a governmental or similar body necessary for the lawful importation,
use, marketing, promotion, distribution, and sale (whether to the public or the private sectors) of the Product in the Territory
including but not limited to regulatory approval;

 

		1.29	“Net Sales” shall mean the amounts invoiced (or that should properly be invoiced)
for Product utilizing any of the Licensed Technology, and that are sold by or on behalf of Licensee or its Affiliates or any sublicensee
of Licensee or its Affiliates to the first person independent of the foregoing in a bona fide arm’s length transaction
without ties to any other product, less the following amounts where they are properly and actually incurred and itemized on invoices:
rebates, discounts, allowances, (but not rebates, discounts or allowances for prompt payments), credits for refunds in respect
of actual returns of Product, and taxes for sales or commodity taxes which are included in the selling price of the Product and
collected as part thereof. Any transaction that is not bona fide arm’s length or that is tied to other products will
be treated for the purpose of “Net Sales” as having been invoiced at the price that ought to have been invoiced at
the prevailing market rate had the transaction been bona fide and arm’s length and without ties to other products;

 

    	4 (42)

    	 

    

 

		1.30	“Non-Conforming Product” shall have the meaning given in Clause 17.8;

 

		1.31	“Patent Rights” shall mean all intellectual and industrial property rights,
including the right to claim priority, the right to sue for past infringements and common law or equitable remedies in respect
of any of the rights, and any renewals, extensions or restorations, and divisional, continuation and reissued applications of the
following rights: (a) (i) the rights in patent applications shown in Appendix II (and patents issued thereon) and all inventions
described therein; and (ii) rights in patents shown in Appendix II and all inventions described therein; and in each of (i) and
(ii), including any substitutions, extensions, reissues, renewals, divisions, confirmations, continuations-in-part, registrations,
and all foreign counterpart patent applications and patents; and (b) (i) rights in all patentable inventions made and patent applications
which are filed for by Licensor or any of its Affiliates during the Term (and patents issued thereon) and that relate to the Product;
and (ii) rights in patentable inventions made and patent applications licensed to or acquired during the Term by Licensor or any
of its Affiliates from third parties and that relate to the Product; and which, in respect of (b)(i) and (ii), in the absence of
a licence, would constitute an infringement of the patents or patent applications listed in Appendix II;

 

		1.32	“Personal Data” means any information relating to an identified or identifiable
natural person contained in the Regulatory and Clinical Trial Data;

 

		1.33	“Product” shall mean Paccal Vet 60 mg vial containing 60 mg of paclitaxel in
nanoparticle formulation (Paclitaxel: Oasmia Novel exciepient XR-17) and any revised or improved, derivative thereto for the use
in the Field or any pharmaceutical preparations that contain or comprise Oasmia Novel exciepent XR-17;

 

		1.34	“Regulatory and Clinical Data” shall mean data and Information: (i) directly
or indirectly generated from any clinical trial in relation to the Product, including all raw data and analyses; (ii) arising from
interactions with Competent Authorities, or drafted or prepared with the intention of being submitted, or which is actually submitted
to any Competent Authority, and all preparatory data and Information that supports or are or might be used to support the foregoing
submissions; 

 

		1.35	“Regulatory Requirements” shall mean all laws, guidelines and notices applicable
in the Territory to the manufacturing, provision, sale, promotion, marketing and clinical testing of the Product, including pharmacovigilance
requirements;

 

		1.36	“Second Source Manufacture” shall have the meaning given in Clause 14.1;

 

		1.37	“Supply Price” shall mean the price extended for the Finished Product by Licensor
to Licensee as set forth in Appendix I;

 

    	5 (42)

    	 

    

 

		1.38	“Term” shall mean the term of this Agreement, from the Effective Date until
its termination or expiry;

 

		1.39	“Territory” shall mean Japan;

 

		1.40	“Trademark” shall mean the trademark or trademarks (registered or unregistered)
under which the Product is from time to time marketed and/or sold and/or provided by Licensee in the Territory;

 

		1.41	“Year” shall mean a calendar year.

 

		1.42	In this Agreement (except where the context otherwise requires):

 

		1.42.1	any reference to a Recital, Clause or Appendix is a reference
to the relevant recital, clause or appendix of or to this Agreement;

 

		1.42.2	the index and clause headings are included for convenience only
and shall not affect the interpretation of this Agreement;

 

		1.42.3	any reference to “persons” includes natural persons,
firms, partnerships, companies, corporations, associations, organisations, governments, governmental agencies and departments,
states, foundations and trusts (in each case whether or not having separate legal personality);

 

		1.42.4	any phrase introduced by the terms “including”, “include”,
“in particular” or any similar expression shall be construed as illustrative and shall not limit the sense of any other
words;

 

		1.42.5	unless otherwise specified, words importing the singular include
the plural, words importing any gender include every gender, and (in each case) vice versa and words importing persons include
all persons;

 

		1.42.6	references to any statute or statutory provision shall include
(i) any subordinate legislation made under it, (ii) any provision which it has modified or re-enacted (whether with or without
modification) and (iii) any provision which subsequently supersedes it or re-enacts it (whether with or without modification).

 

		2.	GRANT OF LICENSE TO PROMOTE AND SELL

 

		2.1	Subject to the terms and conditions of this Agreement, Licensor grants to Licensee the exclusive
right and exclusive license during the Term to: import, promote, use, sell and distribute the Product (i) using the Licensed Technology
in the Territory, and for use in the Field, and, (ii) upon their coming into the ownership or control of Licensor: all Improvements
to the Licensed Technology and all Regulatory and Clinical Data, for use in the Field, in the Territory.

 

    	6 (42)

    	 

    

 

		2.2	Licensor agrees to disclose and provide from time to time to Licensee that Know-how included in
the Licensed Technology and that Regulatory and Clinical Data in the possession or control of Licensor or its Affiliates at the
Effective Date. Appendix IV contains a detailed list of the documented Know-how and Regulatory and Clinical Data to be provided
by Licensor within four (4) weeks of the date of this Agreement, and Licensee agrees that provision by Licensor of the Know-how
and Regulatory and Clinical Data listed in Appendix IV shall constitute a fulfilment of Licensor’s obligations under this
Clause 2.2 with respect to the provision of Know-how and Regulatory and Clinical Data.

 

		2.3	The grant of rights hereunder includes the right to incorporate, use or reference the Know-how
and Regulatory and Clinical Data included in the Licensed Technology with respect to any regulatory filing in the Field within
the Territory and to apply for, hold and maintain Market Authorisation on behalf of Licensor in the Territory.

 

		2.4	During the Term in no case shall Licensor supply the Product to any third party in the Territory
for the use in the Field.

 

		2.5	In addition to the Product in this Agreement, Licensor will give Licensee first refusal right to
develop and distribute any new veterinary product that Licensor brings to the Territory in the future, including Doxophos Vet,
a new and unique anticancer agent currently under preclinical development by Licensor. Licensor shall notify Licensee in writing
of the availability of such new product, the terms and conditions thereof shall be discussed and agreed between the Parties in
a separate agreement within ninety (90) days from receipt of such notice by the Licensee.

 

		3.	GRANT OF LICENSE TO DEVELOP

 

		3.1	Subject to the terms and conditions of this Agreement, Licensor grants to Licensee the exclusive
right and exclusive licence, without the right to grant sublicences, during the Term to conduct and manage at Licensee’s
own expense, clinical trials appropriate for the grant of Marketing Authorisation of the Product in the Territory (“Clinical
Trials”). For the avoidance of doubt, Licensee may outsource the running and management of the Clinical Trials, but must
remain the sponsor.

 

		3.2	Licensor shall supply Product in the Clinical Trial free of charge
to Licensee (“CT Product”). Licensee shall order CT Product at least forty (40) business days in advance of the stated
required delivery date. Delivery of CT Product shall be made to Licensee’s principle office as first above written. Licensor
shall be responsible for packaging, labelling, blinding and randomising the CT Product as appropriate for use in the Clinical Trial.
The terms of Clause 13 shall apply to the supply of CT Product, save that in the case of conflict, the terms of this Clause 3.2
shall apply.

 

    	7 (42)

    	 

    

 

		4.	JOINT STEERING COMMITTEE

 

		4.1	Promptly after the Effective Date, but in any event within ninety (90) days from the Effective
Date, the Parties shall establish a steering committee (the “Committee”) to oversee the Parties' cooperation
and performance under the Agreement including but not limited to the development, manufacturing, marketing and regulatory issues
of the Product to ensure timely supply, development and approval and successful marketing of the Product.

 

		4.2	The Committee shall include an equal number (between two and four (2-4)) of representatives of
each party. The initial members of the Committee are specified in Appendix V. Each of the Parties may replace any or all of its
representatives on the Committee at any time upon written notice to the other in accordance with Clause 35. Each party may, in
its sole discretion, but subject to the written objection of the other party (with demonstrable reason for objection), invite to
attend meetings or portions of such meetings of the Committee, a reasonable number of non-member representative of such party who
have a reasonable purpose for attending such meeting or portion of such meeting. The Committee shall be co-chaired by a representative
of each party, as such representative may be changed by the designating party at the time. The co-chairpersons shall appoint a
secretary of the Committee, and such secretary shall serve for such term as designated by the co-chair persons.

 

		4.3	The Committee shall meet at least every six calendar months, with the first meeting to be held
within six calendar months following the Effective Date, unless otherwise agreed between the Parties. Such meetings shall alternate
between Licensor and Licensee locations (or be held by teleconference or videoconference or other suitable remote meeting system,
if agreed by the Parties) and be held at such times as are mutually agreed upon by the Committee.

 

		4.4	The role of the Committee shall be to facilitate sharing of information between the Parties and
to permit discussion and recommendations, in particular in relation to:

 

		4.4.1	reviewing and evaluating data from pre-clinical studies, clinical
trials and toxicology studies in respect of the Product as it becomes available;

 

		4.4.2	reviewing Licensee’s strategy and plans for marketing the
Product in the Territory;

 

		4.4.3	reviewing regulatory data and regulatory documentation, and the
progress and outcomes of applications to Competent Authorities in the Territory for Marketing Authorisation and determining an
agreed written strategy in respect of the same;

 

    	8 (42)

    	 

    

 

		4.4.4	considering what might be suitable as the Trademark;

 

		4.4.5	considering additional indications for which clinical trials
might be undertaken and applications made to Competent Authorities in the Territory; and

 

		4.4.6	discussing manufacturing and supply and any issues or Improvements
which might be made, and reconciling the quality systems of the Parties, as needed.

 

		4.5	However, each party shall be at liberty to make its own decisions, following discussion in the
Committee, in relation to their respective obligations under this Agreement.

 

		5.	REGISTRATION, APPROVAL ETC. OF THE PRODUCT

 

		5.1	Following the granting of the Marketing Authorisation, but prior to the manufacture of any Product
for delivery to the Territory, Licensor shall ascertain that any and all reasonable requirements of any Competent Authorities applicable
to the manufacture and composition of the Product might be met in the manufacture of the Product by Licensor or its subcontractors,
and Licensor shall identify any reasonably necessary modifications to the manufacturing process necessary to cause the Product
to meet the manufacturing requirements applicable to allow the sale and distribution of the Product in the Territory, save that
it shall be Licensee’s responsibility to ascertain the requirements of the Competent Authorities with respect to the containment,
packaging, storage, transportation and labelling of the Product and to provide this information in sufficient detail to Licensor
to enable Licensor to manufacture the Finished Product.

 

		5.2	Licensee shall use all reasonable endeavours to obtain as soon as reasonably possible, and to thereafter
maintain in its own name but on behalf of Licensor, each Marketing Authorisation for the Product in the Territory that is required
to market, promote and/or sell the Product to all the potential purchasers/ prescribers in the Territory, as soon as reasonably
possible.

 

		5.3	Licensee shall be solely responsible for all communications with the Competent Authorities in relation
to obtaining and maintaining the Marketing Authorisation in the Territory.

 

		5.4	Licensor shall at its commercially reasonable endeavours, support Licensee in obtaining and maintaining
Marketing Authorisation (including registrations or approvals required by the Competent Authorities) for the Product in the Territory,
without any charge. Licensor shall in connection hereto provide to Licensee any advice, assistance, information and data (to the
extent in the possession or control of Licensee) as is necessary in connection with Licensee’s filings and/or correspondence
with the Competent Authorities, at Licensor’s sole expense.

 

    	9 (42)

    	 

    

 

		5.5	Licensor undertakes to perform any tests and/or investigations with regard to the manufacturing
of the Product as are required by any Competent Authority in order to maintain the Marketing Authorisation during the Term.

 

		5.6	If any modifications are made to the Product which require a variation or other change of the Marketing
Authorisations in the Territory as a result of request by Licensee (that is not required by requirements of any Agreed Quality),
it shall be settled in good faith after due consultation between the Parties.

 

		5.7	Licensor and Licensee shall keep each other informed of all developments of which either party
becomes aware with respect to major clinical and commercial relevance and clinical activities in connection with the Product and
competing products on a twice yearly basis at a development meeting to be held alternately at each others premises (or be held
by teleconference or videoconference or other suitable remote meeting system, if agreed by the Parties). In the case of important
events (including without limitation adverse events), the reporting activities have to be immediate and/or more frequent in the
time frame that reflects the severity or importance of the events, as required to comply with all obligations of Licensor and Licensee
in the Territory.

 

		5.8	Each party undertakes to notify the other party within ten (10) business days of receipt of any
correspondence received from any Competent Authority pertaining to the distribution of the Product in the Territory. In case of
urgent matters, such notification shall take place without delay.

 

		5.9	Licensee shall be responsible for agreeing with each Competent Authority the requirements with
respect to packaging and labelling of the Product, including design/artwork, material and text, as well as the form of packaging,
the appearance of the packaging or labelling and the manner of packaging, storage, and handling as required for the Product in
the Territory. Licensee shall provide to Licensor on a regular basis the information and requirements necessary for manufacturing
packaging and labelling from time to time in the Territory and on Licensor’s request proof-read and approve any packaging,
labeling, design/artwork, material and text.

 

		6.	LICENSE FROM LICENSEE

 

		6.1	If during the Term, Licensee acquires ownership or possession of any Improvements and/ or of any
Regulatory and Clinical Data (other than from Licensor or its Affiliates), Licensee shall promptly disclose those Improvements
and/or Regulatory and Clinical Data to Licensor through a written disclosure that reasonably documents all the Improvement(s) and
Regulatory and Clinical Data (as applicable).

 

    	10 (42)

    	 

    

 

		6.2	Subject to the terms and conditions of this Agreement, Licensee grants to Licensor the following
rights with respect to the Improvements and Regulatory and Clinical Data disclosed or to be disclosed pursuant to Clause 6.1:

 

		6.2.1	the exclusive right and license (with the right to grant sublicenses)
during the Term to use any and all such Improvements that are not severable from the Licensed Technology;

 

		6.2.2	the non-exclusive right and license (with the right to grant
sublicenses) during the Term to use any and all such Improvements that are severable from the Licensed Technology; and

 

		6.2.3	the exclusive right and license (with the right to grant sublicenses)
during the Term to use any and all such Regulatory and Clinical Data.

 

in
each case for any and all regulatory and/or sales, promotion and marketing purposes relating to the Product outside the Territory.

 

		6.3	The licence granted pursuant to Clause 6.2.1 and Clause 6.2.3, and sublicenses granted under it
shall be royalty free with respect to uses made by Licensor, its Affiliates and their sublicensees. The licence granted pursuant
to Clause 6.2.2 and sublicenses granted under it shall be discussed in good faith separately.

 

		6.4	Licensee may, but not obligated to support Licensor, at Licensor’s sole expense, if reasonably
requested and on terms negotiated in good faith where Licensee has in its possession or control or is more easily able to obtain,
Information reasonably necessary for the obtaining or maintenance by Licensor of any Marketing Authorisation for the Product outside
the Territory. In consideration of the support practically performed by Licensee, upon Licensor’s request, Licensor shall
compensate Licensee with a reasonable service fee in accordance with the amount mutually agreed in writing between the Parties.

 

		7.	DATA PRIVACY

 

		7.1	Each party (“Data Provider”) shall be responsible for ensuring that it complies with
Data Protection Laws with respect to the provision of Regulatory and Clinical Trial Data to the other party pursuant to this Agreement.
The Data Provider shall ensure as far as is reasonably possible, that all permitted recipients of the Regulatory and Clinical Trial
Data pursuant to this Agreement (“Data Recipients”) shall have the lawful authority pursuant to Data Protection Laws,
to use, store, make copies of and disclose the Regulatory and Clinical Trial Data provided, in the Territory.

 

    	11 (42)

    	 

    

 

		7.2	Without prejudice to the generality of Clause 7.1, each Data Provider shall be responsible for
ensuring that they obtain in advance all necessary and appropriate consents from data subjects allowing information relating to
them and included in Regulatory and Clinical Trial Data, to, pursuant to the Data Protection Laws:

 

		7.2.1	be transferred to any country in the world;

 

		7.2.2	be disclosed to all Data Recipients;

 

		7.2.3	used by Data Recipients for those uses permitted pursuant to
this Agreement, including for:

 

		7.2.3.1	supply to Competent Authorities;

 

		7.2.3.2	supply to persons writing articles for veterinary medical or
other relevant publications; and

 

		7.2.3.3	statistical analysis.

 

		7.3	The Parties shall implement appropriate technical and organisational measures to protect the Personal
Data against unauthorised or unlawful processing and against accidental loss, destruction, damage, alteration or disclosure.

 

		7.4	When implementing and updating technical and organisational measures, each party shall have regard
to:

 

		7.4.1	the sensitive nature of the Personal Data and the substantial
harm which would result from unauthorised or unlawful processing or accidental loss or destruction of or damage to such Personal
Data; and

 

		7.4.2	the state of technological development and the cost of implementing
such measures.

 

		7.5	The Parties shall ensure:

 

		7.5.1	the reliability of any employees, contractors and contractor
personnel who have access to the Personal Data; and

 

		7.5.2	that all employees, contractors and contractor personnel involved
in the processing of the Personal Data have undergone adequate training in the care, protection and handling of the Personal Data.

 

		7.6	Each party shall provide reasonable assistance to the other party to comply with any obligations
under Data Protection Laws and shall not perform its obligations under this Agreement in such a way as to knowingly cause the other
party to breach any of its obligations under Data Protection Laws.

 

    	12 (42)

    	 

    

 

		8.	PHARMACOVIGILANCE

 

		8.1	Licensee, as holder of the Marketing Authorisation, shall be solely responsible for all pharmacovigilance
related obligations required pursuant to the Regulatory Requirements and all related obligations in connection with this Agreement
under applicable laws, regulations and guidelines in the Territory, including without limitation any undertaking necessary to maintain
the Marketing Authorisation. The Parties shall make commercially reasonable efforts to promptly establish and adopt sufficient
procedures concerning such cooperation and the exchange of pharmacovigilance information. These procedures shall be documented
in writing and attached to this Agreement as Appendix IV prior to the first delivery of Product under this Agreement.

 

		8.2	Licensee shall promptly notify Licensor in writing of any adverse events of which Licensee becomes
aware in relation to the Product. Licensor shall provide Licensee any and all information on pharmacovigilance issue in any other
countries outside Territory.

 

		8.3	Licensee shall promptly provide to Licensor copies of all documents containing any negative comments
or feed back, or details of any safety issues, in relation to the Product, its sale, marketing or promotion that is received from
or exchanged with any Competent Authority or other person in accordance with the procedure set forth in Appendix IV.

 

		9.	MARKETING AND SALES

 

		9.1	Licensee shall use its commercially reasonable best efforts to launch the Product within six (6)
months after receipt of notice that it has obtained Marketing Authorisation in the Territory.

 

		9.2	Upon grant of the Marketing Authorisation and Licensee’s launch of the Product, Licensee
shall use its commercially reasonable best efforts to market, offer for sale and maximise sales of the Product in the Territory
for the remainder of the Term.

 

		9.3	Licensee shall be solely responsible for the marketing and promotion costs in the Territory. Licensor
shall at all times use its commercially reasonable endeavours to assist Licensee in promoting the Product in the Territory and
provide Licensee, free of charge, with such information, advertising and promotional materials and documentations available to
Licensor as it shall from time to time considered necessary.

 

    	13 (42)

    	 

    

 

		10.	MILESTONE PAYMENTS

 

		10.1	As consideration to Licensor for the rights granted hereunder and for Licensee's compliance with
the terms and conditions hereof, Licensee shall make milestone payments to Licensor as follows:

 

		(a)	The sum of five hundred and fifty thousand (550 000) Euros within fifteen (15) days at the
Effective Date;

 

		(b)	The sum of seven hundred thousand (700,000) Euros within forty five (45) days of the granting of
Marketing Authorisation;

 

		(c)	The sum of one million (1,000,000) Euros within forty five (45) days when the annual Net Sales
reach seven million five hundred thousand (7,500,000) US dollars for the first time; and

 

		(d)	The sum of one million (1,000,000) Euros forty five (45) days from when the annual Net Sales reach
twelve million five hundred thousand (12,500,000) US dollars for the first time.

 

		10.2	In the event that Marketing Authorisation was not obtained due to Licensor's negligence, or this
Agreement was terminated caused by Licensor’s breach of this Agreement, and/or Licensor permanently withdraws the Finished
Product from the market in the Territory following a Recall as a result of negligence or breach of this Agreement by Licensor,
Licensor shall reimburse Licensee previously received Milestone Payment pursuant to Clause 10.1(a) and (b) and all actual and documental
costs for obtaining Marketing Authorisation, including but not limited to Clinical Trial expenses, within forty five (45) days
from the date of receipt of such invoice issued in writing by Licensee. In the event Marketing Authorisation was not obtained due
to any unavoidable occurrence beyond Licensee's control other than stipulated above Licensor shall reimburse Licensee the Milestone
Payment pursuant to Clause 10.1(a).

 

		11.	ROYALTIES

 

		11.1	In consideration of the license rights granted in the Agreement, Licensee and its Affiliates shall
pay royalties to Licensor which shall be calculated as described in Appendix I.

 

		11.2	Licensee and its Affiliates shall keep and maintain complete and accurate records of the sales
and all necessary and supporting data for calculation of the Net Sales of the Product for each year and shall retain such records
for a period of five (5) years thereafter. Licensor shall have the right to from time to time nominate a firm of independent certified
public accountants acceptable to Licensee to inspect and take copies of such records during reasonable business hours, for the
purpose of verifying, at Licensor's expense, the Net Sales of Licensee and its Affiliates, provided that this right may not be
exercised more than once in any Year, and provided further that such accounting firm shall be first made subject to confidentiality
obligations not more burdensome than those to which the Parties are subject to under this Agreement. If Licensee is required to
reimburse Licensor for an underpayment (in any amount) it shall do so (together with interest payable pursuant to Clause 19.10)
within thirty (30) days of its receipt of notice from Licensor of the result of the accountant's audit. In the event that the accountants'
audit finds that an underpayment of five (5) percent or more has been made by Licensee, Licensee shall reimburse Licensor the cost
of the audit within thirty (30) days of its receipt of notice of the results of the audit.

 

    	14 (42)

    	 

    

 

		11.3	If Licensee sells Product in a currency other than Euro, then for purposes of calculating the royalty
payable, “Net Sales” of such sales shall be computed on the basis of the “spot” conversion rate of the
currency of sale into Euro quoted in the last day of each quarter as of the close of business on the last day of the applicable
accounting and payment period.

 

		11.4	Licensee shall provide Licensor with any documents or information reasonably requested by Licensor
in order to comply with any tax, foreign exchange or other laws relating to this Agreement and payments hereunder. The Parties
shall cooperate with each other for Licensor’s applications and reports to any governmental authorities.

 

		12.	FORECASTING AND ORDERING

 

		12.1	Licensee shall by the 1st January and 1st July each Year provide to Licensor
in writing its forecast requirements of Finished Product for the next twenty four (24) months following either 1st January
or 1st July , as applicable, where (subject to Clause 12.3) the first three (3) months of such forecast shall be considered
a binding purchase order (“Binding Purchase Order”) and the remaining twenty one (21) month forecast shall be
considered a non-binding estimate.

 

		12.2	A non-binding estimate shall be used by Licensor solely for production planning purposes. Licensee
makes no representation and gives no warranty, express or implied, regarding the accuracy of non-binding estimates or that Licensee
will actually order the amount of Finished Product indicated in any such estimate.

 

		12.3	Licensor shall notify Licensee following receipt of a forecast pursuant to Clause 12.1, if its
manufacturing capacity is not likely to be sufficient to meet the anticipated volume requirements of Licensee (taking into account
Licensor’s own and other third parties’ requirements), as well as the volumes of Finished Product that Licensor is
likely to be able to supply during the period of the forecast, then Licensor shall inform Licensee without delay, the volume of
Finished Product Licensor is able to supply by the lead time, and specify when the remaining volume will be available.

 

    	15 (42)

    	 

    

 

		13.	SUPPLY OF PRODUCT

 

		13.1	Licensor shall supply the Finished Product to Licensee in accordance with the terms of this Agreement,
and all other terms (save for those agreed by the Parties) whether express or implied, shall be excluded from any contract for
Finished Product.

 

		13.2	Licensor shall (subject to Clause 12.3), during the Term, manufacture and deliver such quantities
of Finished Product which are ordered by Licensee in writing from time to time within sixty (60) days from the date of Licensee's
Binding Purchase Order pursuant to Clause 12.1.

 

Subject
to the foregoing, Licensor shall confirm in writing each purchase order within five (5) business days from the receipt of the same.

 

		13.3	As part of the Supply Price, Licensor shall package and label Finished Product manufactured by
Licensor according to Clause 13.1 above for distribution by Licensee. As part of the Supply Price, Licensor shall package and label
Products in compliance with the instructions provided by Licensee, provided that Licensor shall have no obligation to implement
new packaging or labelling requirements communicated by Licensee with a lead time of less than two (2) months. If permitted by
rules and regulations in the Territory, Licensor shall be identified as the developer/manufacturer/licensor of the Finished Product
distributed in the Territory. The packaging of the Finished Product, approved by Licensee using supporting documentation provided
by Licensee, shall be: (a) sufficient to protect the Finished Product during shipment, (b) compliant with environmental regulations
or other relevant rules or regulations; and (c) contain the proper labelling as instructed by Licensee pursuant to this Agreement.
Licensee may repackage any Finished Product units.

 

		13.4	Licensor shall use reasonable endeavours to supply the Finished Product and to meet the
delivery date. Without prejudice to any rights or remedies available to Licensee under law or this Agreement, Licensor agrees to
promptly notify Licensee after becoming aware of any actual or anticipated delay in any delivery of Finished Product. In the event
that Licensor could not fulfil the delivery of the Product within three (3) months after the lead time pursuant to Clause 12.1,
then the Licensee shall be entitled to demand Licensor for a compensation which is limited to ten percent (10%) of the value of
the delayed Finished Product.

 

		13.5	All Finished Product delivered by Licensor shall be delivered CIP Arlanda Sweden - Narita Japan
(per Incoterms 2000, made part of this Agreement by reference) or to any other destination specified by Licensee from time to time
within the Territory.

 

    	16 (42)

    	 

    

 

		13.6	Licensee shall use its reasonable endeavours to collect the Finished Product in a prompt manner.
Warehouse or storage costs incurred by Licensor due to Finished Product being left at the point of delivery for an extended period
of time on Licensee’s instructions, or as a result of an act or omission of Licensee, shall be borne by Licensee.

 

		13.7	Risk in the Finished Product shall pass to Licensee upon delivery.

 

		13.8	The title to any consignment of the Finished Product shall not pass to Licensee until Licensor
has received payment in full of the price.

 

		13.9	During such time as title in the Finished Product remains with Licensor, Licensee shall:

 

		13.9.1	store or otherwise keep the Finished Product in such a way as
clearly to indicate at all times that the Finished Product are owned by Licensor and shall not remove, obscure or delete any mark
placed on the Finished Product by Licensor which may enable the Finished Product to be identified; and

 

		13.9.2	have the power to deal with or use the Finished Product (and
other goods in which the Finished Product are incorporated) as fiduciary bailee of Licensor in the normal course of its business
and to dispose of the Finished Product or such goods by way of bona fide sale at full market value. 

 

		13.10	In order to secure the availability and timely delivery of the Finished Product to Licensee, Licensor
agrees to undertake to keep at all times, at its sole costs, expense and responsibility, in its premises a sufficient safety stock
of Finished Product (the “Safety Stock”) designated to Licensee. Such Safety Stock shall correspond to at least
three (3) months of Licensee’s average monthly orders for Finished Product over the previous twelve (12) calendar months
to be assessed and updated at the end of each calendar quarter, and shall be rotated with Licensor’s regular inventory of
Finished Product to maintain shelf life. For the avoidance of doubt, the Parties expressly agree that the costs and expenses incurred
by Licensor as result of keeping such Safety Stock shall be deemed already included in the Supply Price.

 

		13.11	Licensor shall not deliver Finished Product which is not manufactured at an approved facility and
shall not change the manufacturing site and/or the regulatory commitments (which are defined in the Marketing Authorisation documentation
and shall include without limitation manufacturing method and specification) for the Finished Product without obtaining prior written
approval therefore from Licensee and the Competent Authority.

 

		13.12	During the Term and the time which Licensee uses its stock of Finished Product delivered by Licensor,
Licensor shall provide Licensee, and at Licensee’s request also the Competent Authority, with letter(s) of authorisation
as well as any documentation relating to the Finished Product required by Licensee, or such authorities, for Marketing Authorisation.

 

    	17 (42)

    	 

    

 

		13.13	Licensee's right to possession of the Finished Product shall terminate immediately upon the any
of the events listed in Clause 24.2(b) affecting Licensee, or if Licensee encumbers any of the Finished Product.

 

		13.14	Licensee grants Licensor, its agents and employees an irrevocable right at any time to enter any
premises where the Finished Product are or may be stored in order to inspect them, or, where Licensor's right to possession has
terminated, to recover them.

 

		13.15	During the Term Licensee or any Competent Authority shall be entitled upon prior written notice
to visit, inspect and carry out audits relating to the Finished Product at Licensor's facilities, to verify the compliance with
this Agreement. With regard to Licensor such visits shall be arranged during normal working hours within four (4) weeks from the
date of notice. For purposes of such audits, the Parties undertake to co-operate in good faith with each other and provide the
other party with such information and documentation relating to the Finished Product and the manufacture thereof, which it may
reasonably request.

 

		14.	THIRD PARTY MANUFACTURING

 

		14.1	Licensor shall for this Agreement reserve for itself the manufacturing rights and Know-how in relation
to the Finished Product, but hereby agrees at any time, to appoint a subcontracting manufacturer (the “Second Source Manufacturer”)
mutually agreed upon by Licensor and Licensee as a back-up manufacturer of the Finished Product. The Parties agrees not to unreasonably
withhold their consent to the appointment of such Second Source Manufacturer. Licensor shall, following signature by the Second
Source Manufacture of a confidentiality agreement with terms at least as strong as those agreed by the Parties in this Agreement,
deposit with and transfer to the Second Source Manufacturer all Detailed Manufacturing Documentation. Licensor's agreement with
such Second Source Manufacturer must bind the Second Source Manufacturer to the same standards and provisions as applicable to
the Finished Product supply and manufacturing under and subject to this Agreement. Licensor warrants and is ultimately responsible
for the compliance of any such Second Source Manufacturer to the terms and conditions of this Agreement.

 

    	18 (42)

    	 

    

 

		14.2	Licensor shall promptly notify Licensee in the event that Licensor is for any reason at any time
during the Term unable to supply Licensee with the Finished Product as ordered by Licensee according to Clause 12.1, including
without limitation to deliver Finished Product on time or because Licensor is not technically capable of delivering Finished Product
to the specification required by the Marketing Authorisation. If such inability to supply continues for a period exceeding three
(3) months, Licensee shall have the right to order the Finished Product directly from Licensor's supplier or, at Licensee's own
discretion, demand that Licensor without delay transfers the (or some of the, as appropriate) manufacture of the Finished Product
to the Second Source Manufacturer and Licensee shall thereafter have the right to order the Finished Product (or, in the case of
an inability to completely supply some of the volume of Finished Product required, that volume of Finished Product that Licensor
is unable to supply) from the Second Source Manufacturer until such time that Licensor’s inability to supply ceases, to the
satisfaction of Licensee (acting reasonably).

 

		14.3	For the avoidance of doubt, Licensee may not exercise its rights under Clause 14.2 while the Parties
await an award to be rendered in proceedings referred by either party under Clause 14.4. However, in the event that proceedings
are referred by either party under Clause 14.4 and an award is not rendered in such proceedings within thirty (30) days for whatever
reason, Licensee may exercise its rights under Clause 14.2 while the Parties await such an award to be rendered.

 

		14.4	Any dispute between the Parties as to (a) the reasonableness of a party’s objections to one
or more of the preferred Second Source Manufacturers specified by the other party above; or (b) whether the prerequisites for exercising
Licensee’s rights under Clause 14.2 to order the Finished Product from the Second Source Manufacturer are met, shall be submitted
to the dispute resolution procedure set out in Clause 37.

 

		14.5	Licensor shall be solely responsible for any costs associated with or resulting from any manufacturing
site change and Licensor shall be solely responsible for the costs of locating and qualifying a Second Source Manufacturer.

 

		15.	ESCROW

 

		15.1	Upon Licensee's request at any time after the Effective Date and during the Term, the Parties shall
enter into an escrow agreement (the “Escrow Agreement”) with an appropriate third-party escrow agent selected
by Licensor in its reasonable discretion (the “Escrow Agent”). Upon establishment of an escrow account under
the Escrow Agreement, Licensor shall deposit with the Escrow Agent the Detailed Manufacturing Documentation.

 

		15.2	The Escrow Agreement shall irrevocably instruct the Escrow Agent to make all Escrow materials available
to the Second Source Manufacturer in the occurrence of any of the events under Clause 14.2. Licensee shall be responsible for all
fees charged by the Escrow Agent.

 

    	19 (42)

    	 

    

 

		15.3	Upon Licensor's request Licensee shall return and shall procure that any Second Source Manufacturer
shall return any escrow material to Licensor upon the expiration of this Agreement pursuant to Clause 24.1 or the termination of
the Agreement by Licensor for Licensee 's breach pursuant to Clause 24.2(d) or for Licensee 's insolvency or other enumerated circumstance
pursuant to Clause 24.2(b).

 

		16.	SAMPLES

 

		16.1	In order to support marketing and promotion efforts for Finished Product in the Territory, Licensor
shall supply a reasonable quantity of samples of the Finished Product, at no cost to Licensee or its Affiliates, for use in the
Territory. The maximum amount and timing of such samples delivery to Licensee shall be separately agreed in connection with Licensee’s
first Product order from Licensor.

 

		16.2	Sample price to Licensee or its Affiliates shall be half of Licensor's All-In Cost of Goods (as
defined in Appendix I). For the avoidance of doubt, a royalty shall not be payable in respect of any supply of samples by Licensor
or for Finished Product to be used in clinical trials.

 

		17.	QUALITY OF PRODUCT

 

		17.1	Licensor represents and warrants that all amounts of Finished Product delivered and supplied to
Licensee

 

		(a)	shall have been manufactured in accordance with the approved specifications in the Marketing Authorisations,
with the manufacturing methodology set out in the Detailed Manufacturing Documentation, all applicable regulatory requirements
and/or commitments, cGMPs and all applicable laws and regulations in force from time to time;

 

		(b)	shall conform to the Product specifications in the Marketing Authorizations or other specifications
agreed between the Parties and all applicable laws and regulations in force from time to time in the Territory;

 

		(c)	shall have a shelf life of at minimum twelve (12) months when delivered by Licensor pursuant to
Clause 13.5. Minimum shelf life shall be revised by the Parties in the event of a total shelf life extension is applied by Licensor
and is granted by the Competent Authorities.

 

		(d)	the manufacturing facilities utilized for the manufacture of Finished Product shall, at the time
of manufacture, comply with applicable regulations, or other applicable regulations, including applicable cGMPs.

 

    	20 (42)

    	 

    

 

Clause 17.1(a), (b), (c) and
(d) shall together be the “Agreed Quality”.

 

		17.2	Licensor shall furnish Licensee with the analytical test methods information for the Finished Product
prior to Licensee’s first purchase of Finished Product for purposes of Licensee’s inspection.

 

		17.3	Licensor shall with each batch of Finished Product delivered and supplied furnish Licensee with
a certificate of analysis indicating the compliance of that batch of Finished Product with the Marketing Authorisation and Agreed
Quality, and such other information and documentation as may be required from time to time under applicable laws and regulations
in the Territory.

 

		17.4	As soon as possible, but in no case later than ten (10) business days following delivery of Finished
Product from Licensor, Licensee shall: (i) perform a visual inspection of the Finished Product so delivered, to identify any visible
signs of defect or transportation damage, and (ii) notify Licensor promptly should any such defect be found, and in that case place
such Finished Product in Licensee’s warehouse until the claim is settled between the Parties.

 

		17.5	If Licensee becomes aware that a Finished Product delivered is defective, is recalled by any governmental
agency or authority or is not in conformance with the Agreed Quality, Licensee shall notify Licensor in writing without undue delay
after becoming aware thereof.

 

		17.6	Licensee shall have the right to inspect and analyse a representative sample of the Finished Product
delivered by Licensor, as required from time to time. Upon Licensee’s reasonable request, Licensor agrees to provide a sufficient
amount of representative samples of the less to occur as following, (i) five percent (5%) of the delivery, or, (ii) twenty five
(25) vials per year, free of charge to Licensee, for the purpose of such inspection. Notwithstanding what is otherwise said in
Clause 17 if, after inspection by Licensee, Finished Product is reasonably believed not conform to the Product specifications agreed
between the Parties, Licensee may as an interim measure reject the order of relevant batch of the Finished Product and return it
to Licensor, or conduct a full range of inspection thereof for all of the Finished Product, in accordance with all applicable laws
and regulations in the Territory. The costs and expenses incurred for such full range inspection of the Product shall be discussed
in good faith and agreed between the Parties.

 

		17.7	Licensor acknowledges and agrees that Licensee may, subject to applicable mandatory legislation,
from time to time and at its option rely on the certificate of analysis issued by Licensor pursuant to Clause 17.3 herein above
and sell Product delivered by Licensor without testing or inspecting the compliance of Product with the Agreed Quality. Lack of
such testing or inspection by Licensee shall in no way be, or be deemed to be, an acceptance, express or implied, by Licensee of
possible non-conforming or defective Product, and shall be without prejudice to Licensor’s warranty and any remedy available
to Licensee under law or this Agreement.

 

    	21 (42)

    	 

    

 

		17.8	If Licensee finds out that a Product delivered is defective, does not comply with the Agreed Quality,
was shipped in violation of any applicable statute, administrative order or regulation, is recalled by any governmental agency
or authority or by Licensee, is not in conformance with instructions agreed upon by the parties regarding packaging or transport,
or is not suitable for use or sale (“Non-Conforming Product”), Licensee shall notify Licensor in writing without
undue delay after becoming aware thereof. Any claims by Licensee regarding Non-Conforming Finished Product delivered shall specify
in reasonable detail the nature and basis for the claim and cite relevant batch control numbers or other information to enable
specific identification of Finished Product involved.

 

		17.9	Licensor agrees to, at its own expense, review any written claim made by Licensee regarding Non-Conforming
Finished Product and provide Licensee with the results of its review within thirty (30) days after Licensor's receipt of such written
claim. At Licensor’s request and expense, Licensee shall if available return to Licensor for testing the Finished Product
at issue or a representative sample thereof. If Licensor’s test results reasonably confirm the Finished Product as Non-Conforming
Finished Product, Licensee shall return all Non-Conforming Finished Product to Licensor at Licensor’s expense or at Licensor's
discretion destroy such Non-Conforming Finished Product, and Licensor shall, at Licensor's option and sole remedy, either make
a replacement delivery of conforming Finished Product within fourteen (14) days from the receipt of Licensee’s notice or
reimburse Licensee for any payments made for such Non-Conforming Finished Product.

 

		17.10	If Licensor’s test results do not confirm the Finished Product’s non-conformance, and
if the Parties cannot resolve the issue of non-conformance of such Finished Product, Licensor shall submit to a mutually acceptable
independent laboratory located in the Territory, such Finished Product or a representative sample thereof, along with a reference
sample of Finished Product which has previously been confirmed by Licensor as conforming to the Agreed Quality, the test protocols
described in the specifications and mutually agreeable interrogatories to be answered by such laboratory. The determination of
the Finished Product’s conformance or non-conformance to the Agreed Quality shall be binding upon the Parties. If the laboratory
determines that the Finished Product is conforming, Licensee shall pay all independent laboratory and shipping costs incurred by
Licensor. If such laboratory confirms the Finished Product tested as Non-Conforming Finished Product, Licensor shall pay all independent
laboratory costs and shall, at Licensor's option, either make a replacement delivery of conforming Finished Product free of charge
within fourteen (14) days from the date of such laboratory confirmation or reimburse Licensee for any payments made for such Non-Conforming
Finished Product.

 

    	22 (42)

    	 

    

 

		17.11	At any time during review of any claim made by Licensee regarding Finished Product delivered, Licensor
shall, at Licensee’s request, within fourteen (14) days deliver to Licensee such quantities that are requested by Licensee
to replace all or part of the Finished Product referred to in that claim, subject to volume restraints to which Licensor is subject
at that time. Without prejudice to any other rights or remedies available to Licensee under law or this Agreement, Licensee shall
not be obliged to pay Licensor the Supply Price for any replacement Finished Product provided under this Clause and that is subsequently
found to be a Non-Conforming Finished Product.

 

		17.12	Licensor shall maintain an inspection procedure and quality assurance program for the Finished
Product and its production process, which Licensor shall follow for the manufacture of Finished Product units under this Agreement.
Licensee shall have the right to review complete records of all quality system documentation which includes but is not limited
to inspection, corrective action, and quality assurance work performed by Licensor during visits arranged in accordance with Clause
13.15.

 

		18.	PRODUCT RECALL; REGULATORY MATTERS

 

		18.1	In the event that (a) any governmental agency or authority or Competent Authority issues a recall
or takes similar action, in connection with the Finished Product sold or distributed by Licensee in the Territory, or (b) a court
of competent jurisdiction orders such a recall, or (c) Licensor decides to cease distribution and/or sales of the Finished Product
by reason of a possible safety risk (hereinafter “Recall”) then Licensor shall promptly inform Licensee of such
Recall, and Licensor and Licensee shall agree on an appropriate course of action.

 

		18.2	Licensor shall promptly inform Licensee of any notification of any action by, or notification or
other information which it receives (directly or indirectly) from any regulatory or other authority, which (a) raises any material
concerns regarding the safety or efficacy of the Finished Product, or (b) which indicates a reasonable potential for a recall or
market withdrawal of the Finished Product.

 

		18.3	Licensor shall bear all direct costs and expenses of a Recall resulting from Finished Product failing
to meet the Agreed Quality at the date of delivery to Licensee. For the purposes of this Agreement, costs and expenses of Recall
include without limitation the expenses of notification and destruction or return of the Finished Product recalled, and the supply
price (including potential royalties) paid by Licensee for such Finished Product.

 

		19.	SUPPLY PRICE AND PAYMENTS

 

		19.1	Subject to the terms and conditions hereunder, Licensee shall pay the Supply Price set out in Appendix
I.

 

		19.2	Licensor shall invoice Licensee for the Supply Price in relation to Finished Product at the time
of shipment of the Finished Product to Licensee.

 

    	23 (42)

    	 

    

 

		19.3	Licensee shall pay the Supply Price
                                         in accordance with Licensor’s valid invoice within the later of (i) sixty
                                         (60) days from the date of receipt of such invoice, or (ii) seventy (70) days
                                         from the date the invoiced Finished Product has been safely delivered to the destination
                                         specified by Licensee (or such other destination as subsequently agreed by the Parties
                                         in writing), provided that such invoice shall only reference Finished Product that has
                                         been shipped by Licensor at the time of issuance in accordance with a Binding Purchase
                                         Order from Licensee.

 

		19.4	Licensor may appropriate sums received from Licensee against any debt due to Licensor from Licensee,
irrespective of any purported appropriation by Licensee.

 

		19.5	Royalties accruing to Licensor under this Agreement shall be paid by Licensee to Licensor not later
than thirty (30) days following the end of each two (2) calendar quarters during which such royalties accrued.

 

		19.6	Milestones
                                         except signing fee accruing to Licensor under this Agreement shall be paid by Licensee
                                         to Licensor not later than forty five
                                         (45) days following the occurrence of the event triggering Licensor’s right to
                                         receive and Licensee’s obligation to pay the particular milestone.

 

		19.7	All
                                         payments shall be made by bank transfer, or by such other payment method as shall be
                                         stipulated by the relevant party from time to time, to such bank account as that party
                                         may from time to time notify in writing to the other party.

 

		19.8	All sums payable under this Agreement shall be paid in full without any deductions or withholdings
(including deductions or withholdings in respect of items such as income tax, corporation tax, or other taxes, charges or duties)
except insofar as the party obliged to make the payment is required by law to deduct withholding tax from sums payable to the other
party in which case the party making the payment shall:

 

		(i)	ensure that the deduction or withholding does not exceed the minimum amount legally required; and

 

		(ii)	provide to the other as required by the relevant law either an official receipt of the relevant
taxation authorities involved in respect of all amounts so deducted or withheld or if such receipts are not issued by the taxation
authorities concerned a certificate of deduction or equivalent evidence of the relevant deduction or withholding.

 

		19.9	The Parties shall cooperate to ensure that all sums payable under this Agreement can be lawfully
paid without deduction of withholding tax, where this is possible under the laws of the relevant jurisdiction.

 

    	24 (42)

    	 

    

 

		19.10	Each party shall pay to the other interest on payments overdue to that other party (including payments
of royalties pursuant to Clause 11.1) at the rate of six (6) per cent per annum from the date the payment became due until actual
payment is made (irrespective of whether the date of payment is before or after any judgment or award in respect of the same).

 

		20.	REPRESENTATIONS AND WARRANTIES BY LICENSOR

 

		20.1	Licensor warrants and represents that it shall at all times

 

		20.1.1	comply with the Regulatory Requirements;

 

		20.1.2	that the rights granted or to be granted to Licensee pursuant
to this Agreement do not conflict with any rights granted to any third party.

 

		21.	INTELLECTUAL PROPERTY

 

		21.1	Except for those rights expressly granted under this Agreement, nothing in this Agreement shall
be construed as creating, granting or conveying to one party any licence, right, title or other interest in or to any Intellectual
Property Rights owned or controlled by the other party or its Affiliates: (i) existing prior to the Effective Date; or (ii) independently
discovered and developed during the Term by such other party or its Affiliates other than in performance of its obligations under
this Agreement and without use of such other party’s Intellectual Property Rights or Confidential Information.

 

		21.2	Licensor shall be responsible for and undertake, at its own cost in consultation with Licensee,
the filing, prosecution, maintenance and defence of any Patent Rights. Upon request by Licensor, Licensee shall, at Licensor’s
own cost, promptly provide all reasonable assistance requested by Licensor in connection with the filing, prosecution, maintenance
or defence of any Patent Rights.

 

		21.3	Licensor shall have
                                         the right to timely restrain any third party infringement of any Licensor's Patent
                                         in Licensor’s name and at its expense, and shall be solely entitled to any recovery
                                         that results from such enforcement. At Licensor’s reasonable request and expense,
                                         Licensee may be, but shall not be obligated to cooperate in such proceeding. Each party
                                         shall notify the other in the event any third party shall commence or threaten to commence
                                         an action against Licensor or Licensee alleging that the sales of the Finished Product
                                         infringes a patent or other Intellectual Property Right of such third party. Each party
                                         shall keep the other reasonably informed with respect to the progress of any such action
                                         from time to time. Licensor shall, at all times, protect Licensee from any such action
                                         against Licensee, except such action was determined caused by the negligence, fault,
                                         wilful wrongdoing, or material breach of this Agreement by Licensee. Each party shall
                                         be permitted to participate in any such infringement litigation on its own behalf, at
                                         its own expense, through counsel of its choice.

 

    	25 (42)

    	 

    

 

		21.4	Licensor represents and warrants to Licensee as of the date of this Agreement:

 

		(a)	there
                                         have been no claims or assertions, written or oral, that the making, offering
                                         for sale, use, or importing of the Product infringes the patents, trademarks, or other
                                         Intellectual Property Rights of any third party;

 

		(b)	Licensor has no actual knowledge, of
any third party patents, trademarks or other proprietary rights which are valid and which would be infringed by making, having
made, using, selling, offering for sale or importing Product in the Territory in accordance with the terms of this Agreement; and

 

		(c)	Licensor
                                         has no actual knowledge that as a result of the execution and delivery of this
                                         Agreement and the performance of Licensee hereunder, of any violation of, or lose any
                                         rights pursuant to, any license, sublicense or agreement previously provided to a third
                                         party with respect to Licensor’s Intellectual Property Rights.

 

		22.	INDEMNIFICATION AND LIABILITY 

 

		22.1	Without prejudice to any other limitation (whether effective or not) of either party’s liability,
neither party shall be liable (whether in contract, tort (including negligence) or for breach of statutory duty or otherwise) for
any loss of profits, use, opportunity, goodwill, business or anticipated savings, for any indirect or consequential losses in connection
with this Agreement, the services or the Products (in each case irrespective of any negligence or other act, default or omission
of a party (or its employees or agents), and regardless of whether such loss or claim was foreseeable or not or whether the other
has been informed of the possibility of such loss). Nothing in this Clause 22.1 shall however operate to limit or exclude any liability
for fraud.

 

		22.2	Licensor hereby indemnifies Licensee in full and on demand and shall keep Licensee so indemnified
from and against all Losses incurred or suffered by Licensee whether or not foreseeable and howsoever arising, as a result of any
Claim by a third party which alleges that the Finished Product has caused death or personal injury as a direct result of the Finished
Product as delivered to Licensor failing to meet the Agreed Quality. The indemnity in this Clause 22.2 shall not apply where the
Losses or Claim shall have resulted from damage to the Product in transit or in storage following delivery to Licensee.

 

    	26 (42)

    	 

    

 

		22.3	Where a party seeks indemnification pursuant to this Agreement, the following provisions shall
apply:

  

		22.3.1	the party seeking indemnification (“Indemnitee”)
shall notify the other party (“Indemnitor”) in writing promptly, but no later
than forty five (45) days after becoming aware of any Claim in respect of which indemnification may be sought hereunder;

 

		22.3.2	if any action is threatened or brought against the Indemnitee,
it shall notify the Indemnitor of that action within forty five (45) days of the Claim being brought to the Indemnitee’s
attention and the Indemnitor shall have the right but not the obligation, to defend against, control the defence of, and settle
any such claim and if the Indemnitor fails to take action in defence of the Claim within forty five (45) days of the Claim being
notified to the Indemnitor, or if the Indemnitor subsequently ceases to pursue such defence, the Indemnitee shall have the right
but not the obligation to defend the Claim; and

 

		22.3.3	the party not pursuing the defence of a Claim as envisaged in
Clause 22.3.2 shall co-operate as reasonably requested by the other party in the defence of any Claim indemnifiable pursuant to
this Agreement.

 

		22.4	In case that and as far as the Indemnitor takes action in defence of any such Claim, the Indemnitee
shall be entitled to participate in the defence of any such Claim provided, however, the decisions of counsel for the Indemnitor
shall supersede any decisions made by counsel for the Indemnitee.

 

		22.5	The amount of any indemnification payable pursuant to this Agreement shall include all reasonable
legal and professional services costs incurred in respect of the relevant Claim.

 

		22.6	Nothing in this Agreement, or agreements to be entered into pursuant to its terms shall in any
way exclude or limit any party’s liability for death or personal injury caused by its negligence or for fraudulent misrepresentation.

 

		23.	INSURANCE

 

		23.1	During the Term Licensor and Licensee shall each maintain general business and product liability
insurance coverage, sufficient to cover their respective responsibilities and liabilities in this Agreement. Upon request by one
party, the other party shall furnish to the requesting party a certificate of insurance signed by an authorized representative
of the party's insurance underwriter evidencing the insurance coverage required by this Agreement.

 

		24.	TERM AND TERMINATION

 

		24.1	The Agreement enters into force on the Effective Date. Unless terminated earlier by one of the
Parties in accordance with the terms of this Agreement, it shall continue in force in the Territory until terminated by at least
twelve months prior written notice by one party to the other party, which shall have effect either on (and no earlier than):

 

    	27 (42)

    	 

    

 

(i) the date
of last to occur of the following:

 

		24.1.1	ten (10) years from the Effective Date; 

 

		24.1.2	the last expiration of any Licensor's Patents.

 

This Agreement shall be automatically
extended for one (1) year each, unless either party shall have otherwise notify to other party in writing at least six (6) months
prior to the expiry of this Agreement or renewal or extension hereof.

 

		24.2	Notwithstanding Clause 24.1 above, in addition to the termination provisions set forth elsewhere
in this Agreement, the Agreement may be terminated:

 

		(a)	by mutual agreement of the Parties;

 

		(b)	upon written notice having immediate effect by a party if any of the following occur in relation
to the other party:

 

		(i)	the other party suspends, or threatens to suspend, payment of its debts or is unable to pay its
debts as they fall due or admits inability to pay its debts or is deemed unable to pay its debts; or

 

		(ii)	the other party commences negotiations with all or any class of its creditors with a view to rescheduling
any of its debts, or makes a proposal for or enters into any compromise or arrangement with its creditors; or

 

		(iii)	a petition is filed, a notice is given, a resolution is passed, or an order is made, for or in
connection with the winding up of the other party; or

 

		(iv)	an application is made to court, or an order is made, for the appointment of an administrator or
if a notice of intention to appoint an administrator is given or if an administrator is appointed over the other party; or

 

		(v)	a person becomes entitled to appoint a receiver over the assets of the other party or a receiver
is appointed over the assets of the other party; or

 

		(vi)	a creditor or encumbrancer of the other party attaches or takes possession of, or a distress, execution,
sequestration or other such process is levied or enforced on or sued against, the whole or any part of its assets and such attachment
or process is not discharged within fourteen (14) days; or

 

    	28 (42)

    	 

    

 

		(vii)	any event occurs, or proceeding is taken, with respect to the other party in any jurisdiction to
which it is subject that has an effect equivalent or similar to any of the events mentioned in Clause 24.2(b)(i) to (vi);

 

		(c)	by Licensor by written notice to Licensee having immediate effect, if any change of control occurs
in relation to Licensee (unless Licensor has consented to such change of control in advance in writing, such consent not to be
unreasonably withheld or delayed);

 

		(d)	by a party by written notice having immediate if effect, if there is a material breach in the performance
of the other party’s duties and obligations under this Agreement and the party in default has not remedied the default within
sixty (60) days after receipt of written notice (provided that if such default involves any matter relating to the public health
or relates to a matter for which substantial harm shall accrue to the non-defaulting party by such delay (including without limitation
harm to the Marketing Authorisation, registration or patents pertaining to the Product), the defaulting party shall have ten (10)
days following notice from the non-defaulting party in which to remedy such default).

 

		(e)	By a party in the event that such party determines that the results of the second interim analysis
were not a positive outcome.

 

		(f)	By Licensor in the event that Licensee determines that it will not be able to meet its obligations
under this Agreement prior to the first approval of the Product by a Competent Authority.

 

		24.3	In the event of termination for any reason the Parties shall fulfil orders which were accepted
before the end of the Agreement. Licensee shall cease to promote, market, advertise or enter into negotiations for the sale of
the Product and it shall return or, if applicable, assign to Licensor or a third party designated in writing by Licensor all Marketing
Authorisation, Information, Know-how and Confidential Information received from Licensor and pertaining to the Product, in accordance
with Clause 25.

 

		24.4	In the event of termination of this Agreement, Licensee shall be entitled to, at its option, (i)
request Licensor to repurchase quantities of the Product that Licensee holds in stock from Licensor or (ii) sell any quantities
of Product in stock after termination of the Agreement. Licensor shall repurchase from Licensee any Product held in stock at a
price corresponding to the price paid by Licensee plus transportation costs.

 

		25.	POST TERMINATION

 

		25.1	Upon termination or expiration of this Agreement for any reason, Licensee’s rights with respect
to Product shall terminate.

 

    	29 (42)

    	 

    

 

		25.2	Promptly following termination, Licensee shall (without additional payment being required from
Licensor):

 

		25.2.1	transfer to Licensor copies, including annotations, of all data,
reports, records and materials containing Confidential Information and that are in the possession or control of Licensee;

 

		25.2.2	transfer to Licensor all Regulatory and Clinical Data provided
to Licensee by or through Licensor related to the Product;

 

		25.2.3	assign to Licensor all right, title and interest in or for Licensor's insolvency or other enumerated
circumstance pursuant to Clause 24.

 

		25.2.4	transfer to Licensor or its nominee all right, title and interest in and to every Marketing Authorisation
for the Product in the Territory; and

 

		25.2.5	Licensee hereby covenants that Licensee will at its own expense
execute, promptly sign and do all such instruments, applications, documents, acts and things as may reasonably be required by Licensor
give full effect to Clauses 25.2.1 to 25.2.4.

 

		25.3	Upon the expiration and termination of this Agreement, for any reason whatsoever, the Marketing
Authorisation obtained by Licensee during the term of this Agreement in the Territory shall be transferred to Licensor or its designee.
The compensation to transfer the ownership of the Marketing Authorisation shall consist of all the actual and documented costs
paid by Licensee for transferring the original Marketing Authorisation.

 

		25.4	Licensee hereby grants a perpetual and non-terminable, non-exclusive, worldwide, and royalty free
licence (with a right to sublicense) and without any restriction as to use, to all Licensee ́s Improvements (except Improvement
severable from the Licensed Technology pursuant to Clause 6.2.2 hereinabove) and all Regulatory and Clinical Data in existence
at the last day of the Term and with effect from such date. Licensee hereby covenants with Licensor that Licensee will at its own
expense execute, sign and do all such instruments, applications, documents, acts and things as may reasonably be required by Licensor
give full effect to this Clause 25.4.

 

		25.5	Termination or expiration of this Agreement, for whatever reason, will not affect any accrued rights
or liabilities of either party or payments due nor will it affect the coming into force or the continuance in force of Clauses
7, 11.2, 11.4, 15.3, 18.1, 18.2, 22, 23, 24.3, 24.4, 25, 29, 30 and 37 and any other provision of this Agreement which is expressly
or by implication intended to come into or continue in force on or after such termination.

 

    	30 (42)

    	 

    

 

		26.	FORCE MAJEURE

 

		26.1	Neither party shall be under any liability to the other for failure or delay in the performance
of any obligation hereunder or part thereof to the extent and for the period that such performance is prevented by reason of a
case of Force Majeure, provided that the party affected thereby shall give prompt notice to the other party of the date of commencement
of the Force Majeure, the nature thereof, and expected duration; use its best efforts to avoid or remove the Force Majeure to the
extent it is so able to do; and make up, continue on and complete performance when such cause is removed to the extent it is able
to do so. Either party shall be entitled to terminate this Agreement forthwith by giving written notice to the other party if the
performance of this Agreement shall be substantially hindered or prevented for a period exceeding six (6) months due to an event
of Force Majeure affecting either party which cannot be removed or abated.

 

		27.	RELATIONSHIP BETWEEN THE PARTIES

 

		27.1	The relationship between the Parties under the Agreement is that of independent contractors of
which Oasmia Pharmaceutical AB is the Licensor, manufacturer, supplier and seller and Nippon Zenyaku Kogyo Co. Ltd. is the Licensee,
purchaser and distributor and of the Product.

 

		27.2	Neither party has any right or authority to enter into any contracts in the name of or for the
account of the other party, nor to assume or create any obligation of liability of any kind, express or implied, on behalf of the
other party.

 

		27.3	Licensee shall purchase from Licensor or a third party designated by Licensor all Products unless
otherwise agreed in accordance with Clause 14.2.

 

		27.4	Each party shall have the right to perform its rights and obligations under this Agreement through
a wholly owned subsidiary. Each party shall be responsible for the performance of its subsidiary in the same way as if the performance
had been executed by the party itself.

 

		28.	NON-COMPETITION

 

		28.1	During the Term Licensee and its Affiliates will not develop, use or commercialise any new product
directly competing with the Product in the Territory, without the prior written consent by Licensor. A directly competing product
means a veterinary pharmaceutical product with the same mode of action, which is used or can be used as a substitute to the Product
in the Field in the Territory. For the sake of clarity, Licensee shall be free to use for whatever purpose any and all information
and Know-how developed and collected by Licensee that is not obtained from Licensor; provided, however, any information and Know-how
that is developed by or with Licensor in connection with its performance under this Agreement that relates directly to the Product
itself or to improvements, modifications, formulations or future product extensions of the Product shall be the property of Licensor
if not otherwise agreed between the Parties.

 

    	31 (42)

    	 

    

 

		29.	CONFIDENTIAL INFORMATION

 

		29.1	Neither party shall make copies of, disclose or use the Confidential Information of the other party
under any circumstances whether during or after the currency of this Agreement other than to employees, agents or sub-contractors
of such party who are reasonably required to know such Confidential Information for the purposes of this Agreement, in which case
the party concerned shall procure that such Persons undertake to keep such Confidential Information confidential. Each party shall
be responsible for any disclosure by its employees, agents or sub-contractors.

 

		29.2	Clause 29.1 shall not apply to information:

 

		29.2.1	already in the public domain or which comes into the public domain
other than through a breach of Clause 29.1 by a party;

 

		29.2.2	which is already in the possession of the other party free from
any obligation of confidentiality at the time it is/was disclosed to it;

 

		29.2.3	which is developed by a party independently of information provided
by the other party;

 

		29.2.4	where the non-disclosing party to whom the information relates
has expressly approved its disclosure;

 

		29.2.5	which the other party is required by any Competent Authority
or law to disclose but only to the extent of such required disclosure and provided prior notification of such disclosure has been
given to the other party; and

 

		29.2.6	which a party is required by a recognised stock exchange to disclose
but only to the extent of such required disclosure and provided that the disclosing party has first consulted with and taken due
account of any reasonable representations made by the other party.

 

		29.3	Upon termination of this Agreement for whatever reason, the Parties shall each within fourteen
(14) days return to the other all of the other party's Confidential Information.

 

    	32 (42)

    	 

    

 

		30.	STATEMENTS TO PUBLIC

 

		30.1	Neither Licensor nor Licensee shall make or procure or permit the making of any announcement or
statement to the public with respect to this Agreement without the prior consent of the other party, which consent shall not be
unreasonably withheld, subject to any applicable regulatory and/or stock exchange requirements.

 

		30.2	The wording and the timing of any press release or of any other announcement and/or statement to
the public shall have to be agreed upon in advance between the Parties. The Parties agree that announcements and/or statements
to the public shall be promptly reviewed by both Parties, and that any such announcements or statements deemed by Licensor to be
required to fulfil a commitment under the laws applicable to publicly listed companies in Sweden shall be reviewed within two business
days by Licensee, and if Licensor does not receive a response from Licensee within such period, it shall be deemed accepted by
Licensee.

 

		31.	ENTIRE AGREEMENT

 

		31.1	This Agreement constitutes the whole agreement between the Parties and supersedes all previous
agreements between the Parties relating to its subject matter.

 

		31.2	Each party acknowledges that, in entering into this Agreement, it has not relied on, and shall
have no right or remedy in respect of, any statement, representation, assurance or warranty (whether made negligently or innocently)
other than as expressly set out in this Agreement.

 

		31.3	Nothing in this Clause 31 shall limit or exclude any liability for fraud.

 

		32.	AMENDMENTS

 

		32.1	Except as otherwise provided expressly herein, no modification, amendment or supplement to this
Agreement or to the Appendices hereto shall be effective for any purpose except by consent of both Parties and the proper execution
of another written instrument by duly authorized officers of the Parties hereto.

 

		33.	ASSIGNMENT

 

		33.1	Neither party shall assign, transfer, charge or otherwise encumber the Agreement or any right hereunder
without the prior written consent of the other.

 

    	33 (42)

    	 

    

 

		34.	NO WAIVER; REMEDIES

 

		34.1	The failure of either party at any time to require performance by the other party of any provision
of this Agreement shall in no way affect the right of such party to require performance of that provision, and any waiver by either
party of any breach of any provision of this Agreement shall not be construed as a waiver of any continuing or succeeding breach
of such provision, a waiver of the provision itself, or a waiver of any right under this Agreement.

 

		35.	NOTICES

 

		35.1	Any communication, including any notice or demand, under or in connection with this Agreement must
be in writing, in English, and will be deemed to be validly served if delivered personally (when delivered) or sent by confirmed
fax (when confirmed), by reputable courier within five (5) days of sending (or as otherwise specified in this Agreement):

 

To
Licensor: 

 

			Oasmia Pharmaceutical AB

			Att: Chief Executive Officer

			Vallongatan 1

			S-752 28 Uppsala Sweden

			Telephone:+46 18 50 54 40

			Fax: +46 18 51 08 73

 

and to Licensee:

 

Nippon
Zenyaku Kogyo Co. Ltd

Att.
Chief Executive Officer

Principal Office: 1-1 Tairanoue
Sasagawa,

Asaka-machi,
Kooriyama,

Fukushima
963-0196 Japan

Telephone:+81
24 945 2394

		Fax:	+81 24 946 5630

 

A party may change its designated
address, telephone number or facsimile number by providing notice of such change to the other party under this Clause.

 

    	34 (42)

    	 

    

 

		36.	SEVERABILITY AND VALIDITY

 

		36.1	Any provision of this Agreement that is declared invalid or unenforceable in any jurisdiction shall,
as to such jurisdiction, be ineffective to the extent of such invalidity or unenforceability without invalidating the remaining
provisions hereof, to the extent that the purpose of this Agreement is not materially altered, or without affecting the validity
or enforceability of such provision in any other jurisdiction. Notwithstanding the foregoing, if the purpose of the Agreement has
been materially altered, a party may terminate this Agreement.

 

		37.	GOVERNING LAW AND DISPUTE RESOLUTION

 

		37.1	This Agreement and the documents to be entered into pursuant to it, and any dispute or claim arising
out of or in connection with it or its subject matter or formation, including any question regarding its existence, validity or
termination, (including non-contractual disputes or claims). (“Dispute”) shall be governed by and construed
in accordance with the law of England.

 

		37.2	A conciliation committee shall be installed by both Parties. The conciliation committee shall attempt
to resolve any Dispute by mutual agreement. The conciliation committee shall consist of the Managing Directors (or equivalent)
of the Parties as well as two additional authorised designees from each party. In case the conciliation committee has not resolved
the Dispute within thirty (30) days (fifteen (15) days for Disputes relating to amounts owed) after the Dispute has been referred
to it by either of the Parties, either of the Parties may resort to Clause 37.3. In the event the Dispute relates to amounts owed
by one party to the other, all amounts not in dispute must be timely paid and only the difference between the amounts asserted
by the Parties shall be subject to delay. This Clause 37.2 shall be without prejudice to either party’s rights to seek interim
relief from the courts to protect its confidential information, rights or assets.

 

		37.3	Save as otherwise provided in Clause 37.2, Disputes shall be referred to and finally resolved by
arbitration under the International Chamber of Commerce Rules, which Rules are deemed incorporated by reference into this Clause.
The number of arbitrators shall be one. The seat or legal place of the arbitration shall be Stockholm, Sweden, in case Licensee
is the respondent, and Tokyo, Japan, in case Licensor is the respondent. The language to be used in the arbitral proceedings shall
be English. The award shall be final and binding upon both Parties.

 

    	35 (42)

    	 

    

 

IN WITNESS WHEREOF, the Parties hereto
have caused this Agreement to be executed as a DEED and delivered by their respective, duly authorized officers, as of the day
and year first above written.

 

	SIGNED as a DEED on behalf of Oasmia Pharmaceutical AB, Vallongatan 1, S-752 28 Uppsala, Sweden, a company incorporated in Sweden, by Julian Aleksov, being a person who, in accordance with the laws of that territory, is acting under the authority of the company.	 
	 	 
	                                                                      Authorised
    signatory
	 	 
	SIGNED as a DEED on behalf of Nippon Zenyaku Kogyo Co. Ltd.,  1-1 Tairanoue
    Sasagawa, Asaka-machi, Kooriyama City, Fukushima Prefecture 963-0196, Japan, a company
    incorporated in Japan by                                                     being
    a person who, in accordance with the laws of that territory, is acting under the authority of the company.	 
	 	 
	                                                                      Authorised
    signatory

 

    	36 (42)

    	 

    

 

APPENDIX I

 

Supply Price and Royalties

 

In this Appendix I:

 

“All-In Cost-of-Goods”:
shall mean all direct out-of-pocket costs and Allocable Overhead incurred in the manufacture, packaging, storage and delivery CIP
to Stockholm - Arlanda Airport destination Narita Airport Licensee’s principal office of the Product;

 

“Allocable Overhead”
shall mean with respect to a party’s activities, costs directly related to such activities and incremental costs actually
incurred by such party or for its account, including but not limited to, those which are attributable to such party’s supervisory
services, quality control, occupancy costs, financial costs and its payroll, information systems, delivery systems, or purchasing
functions and which are allocated to company departments based on space occupied or headcount or other activity-based method consistently
applied by such party. Allocable Overhead shall not include any costs attributable to general corporate activities including by
way of example, executive management, investor relations, business development, legal affairs, human relations, related to activities.

 

“Gross Profit”
shall mean Net Sales less All-In Cost-of-Goods of the Product.

 

The Supply Price and royalty
for Finished Product delivered to Licensee throughout the term of the Agreement shall be calculated as follows:

 

		1.	Licensee buys Finished Product from Licensor at Licensor actual All-In Cost-of-Goods (“Supply
Price”)

 

		a.	This Supply Price may be revised by Licensor at Licensor’s discretion or/and upon Licensee’s
request once per year, to be effective by May 1 the following year, giving at least three month’s written notice.

 

		b.	Licensor shall annually furnish to Licensee the statement of All-in Cost-of-Goods within thirty
(30) days from January 1.

 

		c.	Any change in Supply Price may only include Licensor's documented increased/decreased All-in Cost-of-Goods,
to be furnished to Licensee.

 

		d.	Any change in Supply Price shall not affect the Supply Price for orders already submitted.

 

    	37 (42)

    	 

    

 

		2.	Licensee sells the Product and books Net Sales and Gross Profit in the Territory

 

		a.	A quarterly reconciliation of Net Sales is done at the end of each 2 calendar quarters on a Territory
level

 

		3.	A royalty is paid to Licensor within thirty (30) days after the end of each 2 calendar quarters,
calculated as

 

		(a)	Twenty seven (27) % of Licensee’s or its Affiliate's reconciliated Gross Profit for Licensee’s
or its Affiliate's reconciliated Net Sales up to seven million and five hundred thousand US dollars (7.5 million USD) during a
Fiscal Year.

 

		(b)	Thirty six (36) % of Licensee's or its Affiliate's reconciliated Gross Profit for Licensee’s
or its Affiliate's reconciliated Net Sales above seven million and five hundred thousand US dollars (7.5 million USD) during a
Fiscal Year.

 

    	38 (42)

    	 

    

 

APPENDIX II

 

Patents and Trademarks

 

Patents

 

Taxol
containing composition. JP No. 4147114 granted March 5, 2002.

 

Water
insoluble PCT/SE 2008/051515 International patent application.

 

New Ligands JP 2000-598508

 

Trademark

 

Paccal Vet Reg. No. 100 23 18, 12.03.2009.

 

    	39 (42)

    	 

    

 

APPENDIX III

 

Pharmacovigilance Agreement

 

To be agreed upon by the Parties before grant
of Marketing Authorisation.

 

    	40 (42)

    	 

    

 

APPENDIX IV

 

Know-how: documentation

 

		1.	Regulatory documentation

		2.	Pre-clinical documentation

		3.	Clinical documentation

		4.	Chemical and manufacturing documentation

 

    	41 (42)

    	 

    

 

APPENDIX V

 

Committee Members

 

Three members to be appointed by each of the parties from time
to time.

 

    	42 (42)

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00247-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00247-of-00352.parquet"}]]