Exhibit 10.1


 


Certain identified information
has been excluded from this exhibit because it is both not material and is the type that the registrant treats as private or confidential.
Information that was omitted has been noted in this document with a placeholder identified by the mark “[***]”.


 





 



 


COMMERCIALIZATION AGREEMENT


 


BETWEEN


 


CALLIDITAS THERAPEUTICS AB


 


AND


 


STADA ARZNEIMITTEL AG


 





 



 


Dated July 21, 2021


 






     


     


    

 


	Table
    of Contents	 
	 	Page
	 	 
	Article 1
    DEFINITIONS	1
	 	 
	Article 2
    CLINICAL DEVELOPMENT AND REGULATORY APPROVAL	11
	 	 
	Article 3
    GRANT OF RIGHTS	17
	 	 
	Article 4
    MANAGEMENT	25
	 	 
	Article 5
    COMMERCIALIZATION	27
	 	 
	Article 6
    PAYMENTS	29
	 	 
	Article 7
    INTELLECTUAL PROPERTY	34
	 	 
	Article 8
    CONFIDENTIALITY AND DATA PROTECTION	40
	 	 
	Article 9
    PUBLIC ANNOUNCEMENTS; USE OF NAMES	43
	 	 
	Article 10
    REPRESENTATIONS, WARRANTIES AND COVENANTS	44
	 	 
	Article 11
    INDEMNIFICATION AND LIMITATION OF LIABILITY	49
	 	 
	Article 12
    TERM AND TERMINATION	50
	 	 
	Article 13
    MISCELLANEOUS	54




 






    i


     


    

 


COMMERCIALIZATION AGREEMENT


 


This COMMERCIALIZATION AGREEMENT
(this “Agreement”) is made and effective as of July 21, 2021 (the “Effective Date”) by and
among Calliditas Therapeutics AB, a company organized under the laws of Sweden, with company registration number 556659-9766 and
its registered office and mailing address at PO Box 70351, SE-107 24 Stockholm, Sweden and its principal office and address for courier
delivery at Kungsbron 1, C8, SE-111 22 Stockholm, Sweden (“Calliditas”) and STADA Arzneimittel AG, a company
organized under the laws of Germany, with a registered office at Stadastrasse 2-18, 61118 Bad Vilbel, Germany (“Partner”)
(each of Calliditas and Partner being a “Party,” and collectively, the “Parties”).


 


WHEREAS, Calliditas has developed
a pharmaceutical product, which consists of a proprietary oral formulation of budesonide targeted for delayed and sustained release in
the small intestine. Calliditas has designed and completed certain successful clinical trials for the Product (as defined below), established
manufacturing methodologies and capabilities for the Product, prepared and filed certain Regulatory Submissions (as defined below), and
developed and owns, or has exclusive rights to, certain patents and know-how relating to the Product;


 


WHEREAS, Partner desires
to obtain a license to commercialize, distribute, import and sell the Product in the Partner Territory (as defined below) and to obtain
the supply of the Product from Calliditas, and Calliditas is willing to grant such license and provide such supply on the terms and conditions
set forth below and the Supply Agreement; and


 


NOW THEREFORE, in consideration
of the mutual promises and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, the Parties agree as follows:


 


Article 1


 


DEFINITIONS


 


The following terms, whether
used in the singular or the plural, shall have the meanings designated to them under this Article, unless otherwise specifically indicated.


 


1.1            “Acquirer”
means, collectively, with respect to a Change of Control of a Party, the Third Party referenced in the definition of Change of Control
and such Third Party’s Affiliates, determined as of immediately prior to the closing of such Change of Control.


 


1.2            “Affiliate”
means any Person controlled by, controlling, or under common control with a Party. For purposes of the definition of “Affiliate,”
 “control” and, with corresponding meanings, the terms “controlled by,” “controlling,” and “under
common control with” means (a) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities,
participating profit interest, or other ownership interests of a legal entity, or (b) the possession, directly or indirectly, of
the power to direct the management or policies of a legal entity, whether through the ownership of voting securities or by contract relating
to voting rights or corporate governance.


 






    1


     


    

 


1.3            “Agreement”
has the meaning set forth in the Preamble.


 


1.4            “Alliance
Manager” has the meaning set forth in Article 4.1(a).


 


1.5            “Applicable
Laws” means applicable federal, national, foreign, supranational, state, provincial or local or administrative statute, law,
ordinance, rule, code or regulation or orders, injunctions, decrees of any court, administrative agency or similar authority.


 


1.6            “Applicable
Senior Officers” means with respect to Partner, its Senior Executive Officer or the respective competent Executive Vice President,
and with respect to Calliditas, its Chief Executive Officer.


 


1.7            “Budesonide” means (a) the compound described as budesonide(16α,17-[(RS)-Butan-1,1-diyldioxy]-11β,21-dihydroxypregna-1,4-dien-3,20-dion) or (b) any [***]
of the foregoing (a), or any combination thereof.





 


1.8            “Business
Day” means any day except (a) Saturday, (b) Sunday or (c) a day that is a public holiday in Stockholm, Sweden or
Bad Vilbel, Germany.


 


1.9            “Calendar
Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1
and October 1; provided that the first Calendar Quarter of the Term will commence on the Effective Date and end on the day
immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and
the last Calendar Quarter will end on the last day of the Term.


 


1.10          “Calendar
Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31;
provided that the first Calendar Year of the Term will commence on the Effective Date and end on December 31 of the year
in which the Effective Date occurs, and the last Calendar Year will end on the last day of the Term.


 


1.11          “Calliditas”
has the meaning set forth in the Preamble.


 


1.12          “Calliditas
Confidential Information” has the meaning set forth in Article 8.1.


 


1.13          “Calliditas
Indemnitees” has the meaning set forth in Article 11.1.


 


1.14          “Calliditas
Territory” means all countries of the world other than the Partner Territory.


 


1.15          “Calliditas
Trademarks” means the trademark applications and registrations filed with the EMA for the Product and identified in Schedule 1.


 


1.16          “Change
of Control” means, with respect to a Party, (i) a merger or consolidation involving such Party, as a result of which a
Third Party acquires direct or indirect beneficial ownership of more than fifty percent (50%) of the voting power of the outstanding
securities or other ownership interests of the surviving entity immediately after such merger, reorganization or consolidation, (ii) a
transaction or series of related transactions in which a Third Party, together with its Affiliates (determined as of immediately prior
to the closing of the first such transaction), becomes the direct or indirect beneficial owner of more than fifty percent (50%) of the
combined voting power of the outstanding securities or other ownership interests of such Party, or (iii) the sale or other transfer
to a Third Party of all or substantially all of such Party’s and its controlled Affiliates’ assets, but excluding with regard
to (i) to (iii) [***].


 






    2


     


    

 


1.17            “Claims”
has the meaning set forth in Article 11.1.


 


1.18            “Clinical
Trial” means any clinical studies and tests in human subjects of the Product or any Combination or Combined Dosage Therapy
Product.


 


1.19            “Combination
or Combined Dosage Therapy Product” means a pharmaceutical product consisting of both (a) a Product and (b) [***].


 


1.20            “Commercialization”
means, with respect to the Product or a Combination or Combined Dosage Therapy Product, any and all activities directed to marketing,
promoting, distributing, importing for commercial sale, using for commercial purposes, offering to sell, selling or having sold such
product, including conduct of medical affairs activities and commercial activities conducted in preparation for launch of such product,
including secondary packaging, labeling and serialization and activities directed to obtaining (as applicable) and maintaining Regulatory
Approval and also obtaining and maintaining the Unconditional Regulatory Approval, but not including Manufacturing. “Commercialize”
and “Commercialized” have a correlative meaning.


 


1.21            “Commercialization
Plan” has the meaning set forth in Article 5.2.


 


1.22            “Commercially
Reasonable Efforts” means [***].


 


1.23            “Competing
Product” means any pharmaceutical product (other than the Product) that [***].


 


1.24            “Competitive
Infringement” means the making, using, selling, offering for sale, or importing, by any Third Party (other than any Third Party
authorized by a Party with respect to the Product), of any pharmaceutical product that is Covered by any Valid Claim of any Licensed
Patent or Patent within New Calliditas IP. For the avoidance of doubt, filing of an Abbreviated New Drug Application, or equivalent action
outside of the United States that would constitute an act of patent infringement under Applicable Laws, with any applicable Governmental
Authority with respect to a Product as the reference product by any such Third Party will be deemed to be Competitive Infringement.


 


1.25            “Conditional
Regulatory Approval” means a Regulatory Approval granted according to Art. 14 (7) Council Regulation (EC) No 726/2004.


 


1.26            “Confidential
Information” has the meaning set forth in Article 8.1.


 


1.27            “Controlled”
means, with respect to any Patents or item of Know-How or other right, that a Party or such Party’s Affiliate (other than Excluded
Partner Affiliates) owns or has a license to such item or right (other than pursuant to this Agreement) and has the ability to grant
to the other Party a license, sublicense, or rights of access and use under such item or right as provided for in this Agreement without
violating the terms or conditions of any agreement or other arrangement with any Third Party in existence as of the time such Party would
be required hereunder to grant such license, sublicense, or rights of access and use; provided that if there is a Change of Control
of a Party during the Term, such Party will be deemed not to Control any Patents, Know-How or other right that is owned or in-licensed
(prior to the closing of such Change of Control or at any time thereafter) by the Acquirer of such Party, unless such Party has in-licensed
any such Patents, Know-How or other right from the Acquirer prior to the closing of such Change of Control. “Control”
has a correlative meaning.


 






    3


     


    

 


1.28            “Cover”
means, with respect to a given product and a given Patent in a given country, that, absent a license hereunder, the sale, offer for sale
or importation of such product in such country would infringe a claim of such Patent, or in the case of a Patent that is a pending patent
application, would infringe a claim pending in such patent application if it were to issue as a patent. “Covering”
and “Covered” have a correlative meaning.


 


1.29            “Development”
means to discover, research or otherwise develop a process, compound or product, including conducting non-clinical, pre-clinical and
clinical research and development activities, including toxicology, pharmacology and other pre-clinical development efforts, test method
development and stability testing, process development, formulation development, delivery system development, quality assurance and quality
control development, statistical analysis, clinical pharmacology, clinical studies (including Clinical Trials and pre-approval studies),
regulatory affairs and clinical study regulatory activities. Notwithstanding the foregoing, “Development” excludes (a) Commercialization
and (b) Manufacture. “Develop” and “Developed” have a correlative meaning.


 


1.30            “Development
Milestone Event” has the meaning set forth in Article 6.2(a).


 


1.31            “Development
Milestone Payment” has the meaning set forth in Article 6.2(a).


 


1.32            “Disclosing
Party” has the meaning set forth in Article 8.1.


 


1.33            “Dispute”
has the meaning set forth in Article 13.11(a).


 


1.34            “Effective
Date” has the meaning set forth in the Preamble.


 


1.35            “EEA”
or “European Economic Area” means the means the organization of member states as it may be constituted from time to
time, which as of the Effective Date consists of the EU member states and Iceland, Liechtenstein and Norway.


 


1.36            “EMA”
means the European Medicines Agency.


 


1.37            “ERA”
has the meaning set forth in Article 2.2(b).


 


1.38            “European
Union” or “EU” means the organization of member states as it may be constituted from time to time, which
as of the Effective Date consists of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain and Sweden.


 






    4


     


    

 


1.39            “Excluded
Partner Affiliate” means, with regard Partner, [***].


 


1.40            “FD&C
Act” means the U.S. Federal Food, Drug, and Cosmetics Act (21 U.S.C. Section 301 et seq.), as amended.


 


1.41            “FDA”
means the U.S. Food and Drug Administration.


 


1.42            “Field”
means all therapeutic uses of the Product, in the indication of IgA nephropathy, whether as monotherapy or in form of a Combination or
Combined Dosage Therapy Product.


 


1.43            “First
Commercial Sale” means, with respect to the Product and a country in the Partner Territory, the first sale, transfer or disposition
for value by or on behalf of Partner or any of its Affiliates to a Third Party in such country after Regulatory Approval for such Product
has been obtained in such country, or, as applicable and permitted in such country before such Regulatory Approval has been obtained,
pursuant [***]. A First Commercial Sale excludes any transfer or other distribution of the Product as promotional sample to physicians
or hospitals in amounts consistent with industry practice and consistent with prevailing industry standards, or of a Product transferred
or disposed at no charge for research, preclinical, clinical, or regulatory purposes or in connection with patient assistance, compassionate
use, “right-to-try” use, indigent programs or other charitable purposes (in each case except to the extent reimbursed by
a third-party payor) or of a Product for investigator-initiated trials or on a named patient basis.


 


1.44            “FTE
Costs” means, with respect to a period, the FTE Rate times the number of FTEs, or portion thereof, actually utilized in performing
activities under this Agreement during such period.


 


1.45            “FTE
Rate” means a rate of [***] EUR per FTE per year. The FTE Rate is “fully burdened” and will include employee salaries
and all overhead allocated to such employee’s work hereunder. FTE as used in this definition means the equivalent of a full-time
individual’s work for a twelve (12) month period (consisting of [***] hours per year).


 


1.46            “Future
Commercialization Transaction” has the meaning set forth in Article 12.3(i).


 


1.47            “GDPR”
means the General Data Protection Regulation (EU) 2016/679.


 


1.48            “Generic
Version” means, with respect to the Product, a product that is granted Regulatory Approval in the relevant country of the Partner
Territory after the Effective Date and is (a) determined by the applicable Regulatory Authority or by Applicable Law in the relevant
country of the Partner Territory to be “comparable,” or “interchangeable” to the Product and can be prescribed
for use in [***], or (b) [***].


 






    5


     


    

 


1.49            “Governmental
Authority” means any applicable government authority, court, tribunal, arbitrator, agency, department, legislative body, commission
or other instrumentality of (a) any government of any country or territory, (b) any nation, state, province, county, city or
other political subdivision thereof or (c) any supranational body.


 


1.50            “Improved
Product” means [***]. “Improved Product” includes in particular [***], but excludes any [***].


 


1.51            “Improvements”
means [***].


 


1.52            “Indemnitee”
has the meaning set forth in Article 11.2.


 


1.53            “Indemnitor”
has the meaning set forth in Article 11.2.


 


1.54            “Initiating
Party” has the meaning set forth in Article 7.5(c).


 


1.55            “Insolvency
Event” means (a) a Party suspends payment of its debts or admits inability to pay its debts, or is deemed unable to pay
its debts within the meaning of Applicable Law; (b) a 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 any class of its creditors
generally; (c) in relation to a Party, 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 a Party; (d) an application is made to court, or an order is made, for the appointment of an
administrator, or a notice of intention to appoint an administrator is given or an administrator is appointed, over a Party; (e) a
receiver is appointed over all or any of the assets of a Party; or (f) any analogous demand, appointment or procedure is instituted
or occurs in relation to a Party in any jurisdiction in which the Party carries on business.


 


1.56            “JSC”
has the meaning set forth in Article 4.1.


 


1.57            “Know-How”
means and includes conceptions, ideas, reductions-to-practice, innovations, inventions, trade secrets, technology, processes, practices,
formulae, instructions, procedures, assembly procedures, results (including biological, chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical, preclinical, clinical, safety, manufacturing and quality control data, including study designs and protocols),
machines, equipment, compositions of matter, compounds, formulations, genetic material, improvements, enhancements, modifications, technological
developments, know-how, methods, treatments, techniques, systems, designs, artwork, drawings, plans, specifications, documentation, data
and information, customer lists, textual or graphical works, packaging, marketing materials, display material, logos and slogans, in
each case whether or not confidential, proprietary, patentable, copyrightable, or susceptible to any other form of legal protection (whether
registered or not), in written, electronic or any other form.


 


1.58            “Licensed
Intellectual Property” means, collectively, the Licensed Patents and the Licensed Know-How.


 






    6


     


    

 


1.59            “Licensed
Know-How” means, subject to Article 3.6, any and all Know-How Controlled by Calliditas or any of its Affiliates (solely
or jointly with any Third Party) as of the Effective Date or during the Term, and which is [***].


 


1.60            “Licensed
Patents” means, subject to Article 3.6, any and all Patents in the Partner Territory Controlled by Calliditas or any of
its Affiliates (solely or jointly with any Third Party) as of the Effective Date or during the Term, which (a) [***]; and (b) [***].
The Licensed Patents as of the Effective Date are identified in Schedule 3. Licensed Patents [***].


 


1.61            “Losses”
has the meaning set forth in Article 11.1.


 


1.62            “MAA”
means a Marketing Authorization Application filed with the EMA under the centralized European procedure (including amendments and supplements
thereto) in respect of the Product in the Field.


 


1.63            “Major
Market Countries” means [***].


 


1.64            “Manufacture”
means all activities related to the making, having made, production, manufacture, processing, filling, finishing, packaging, labeling,
shipping and holding of the Product or a Combination or Combined Dosage Therapy Product, including [***], but excluding [***]. “Manufactured”
and “Manufacturing” have a correlative meaning.


 


1.65            “Minimum
Royalties” has the meaning set forth in Article 6.5(e).


 


1.66            “Net
Sales” means, with respect to the Product, the gross amount invoiced by Partner or its Affiliates for the sale or supply of
such Product to a Third Party (including distributors), less only the following deductions (without duplications) to the extent appropriately
allocated to the sale of such Product in accordance with Partner’s or its Affiliates’ accounting standards as consistently
applied, and actually taken, paid, accrued, or allowed, or included in the gross sales prices or specifically allocated in its financial
statements with respect to such sales of Product:


 


(a)            [***];


 


(b)            [***];


 


(c)            [***];


 


(d)            [***];


 


(e)            [***];
and


 


(f)            [***].


 






    7


     


    

 


Notwithstanding the foregoing:


 


(i)            Sales
between Partner and its Affiliates shall be disregarded for purposes of calculating Net Sales unless there is no subsequent sale of the
Product to a Third Party.


 


(ii)            [***].


 


(iii)           [***].


 


(iv)           [***].


 


Net Sales exclude [***].


 


[***].


 


1.67            “New
Calliditas IP” has the meaning set forth in Article 7.3(a).


 


1.68            “New
Joint IP” has the meaning set forth in Article 7.3(c).


 


1.69            “New
Partner IP” has the meaning set forth in Article 7.3(b).


 


1.70            “Non-Initiating
Party” has the meaning set forth in Article 7.5(c).


 


1.71            “Ongoing
Clinical Trial” means NefIgArd, Calliditas’ global pivotal Phase 3 Clinical Trial and the related open label extension
Clinical Trial in primary IgA nephropathy on-going as of the Effective Date.


 


1.72            “Orphan
Designation” means the orphan designation EU/3/16/1778 granted by the European Commission on 18 November 2016.


 


1.73            “Partner”
has the meaning set forth in the Preamble.


 


1.74            “Partner
Confidential Information” has the meaning set forth in Article 8.1.


 


1.75            “Partner
Controlled Patents” has the meaning set forth in Article 7.4(c).


 


1.76            “Partner
Indemnitees” has the meaning set forth in Article 11.1.


 


1.77            “Partner
Initial Commercialization Plan” means the commercialization plan to be provided by Partner to Calliditas pursuant to Article 5.3.


 


1.78            “Partner
Territory” means the EEA, the United Kingdom and Switzerland.


 


1.79            “Party”
or “Parties” has the meaning set forth in the Preamble.


 


1.80            “Patent”
means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all
patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority
from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued
prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications
((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all extensions
or restorations by existing or future extension or restoration mechanisms, including revalidations, renewals, reissues, re-examinations
and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a),
(b), and (c)).


 






    8


     


    

 


1.81            “Patent
Challenge” has the meaning set forth in Article 12.2(d).


 


1.82            “Person”
means any individual, corporation, partnership (whether general, limited or limited liability), joint-stock company, unincorporated organization
or other legal entity having legal personality or the right to sue in its own name.


 


1.83            “Pharmacovigilance
Agreement” has the meaning set forth in Article 2.11.


 


1.84            “PIP”
has the meaning set forth in Article 2.5(a).


 


1.85            “Pricing
Approval” means all approvals, agreements, determinations, or decisions establishing prices that can be charged to end users
or consumers for the Product or that shall be reimbursed by Regulatory Authorities for a Product, in each case that are necessary for
effective market access and generally obtained before commercial product launch in a country in the Territory where Regulatory Authorities
approve or determine pricing for pharmaceutical products for reimbursement or otherwise.


 


1.86            “Product”
means (a) Budesonide modified release 4 mg capsules being studied in the Ongoing Clinical Trial, in all presentations and package
configurations, and (b) any Improved Product [***].


 


1.87            “Product
Income” means [***].


 


1.88            “Quality
Agreement” has the meaning set forth in Article 5.1.


 


1.89            “Receiving
Party” has the meaning set forth in Article 8.1.


 


1.90            “Regulatory
Approval” means, for the Product with respect to a country in the Territory, all permissions, approvals, licenses, registrations,
authorizations, or clearances of any Regulatory Authority that are necessary for the sale of such Product in such country in the Territory,
including approval of the MAA.


 


1.91            “Regulatory
Authority” means any domestic (federal or state), supranational or foreign court, commission or governmental, regulatory or
administrative body, board, bureau, agency, instrumentality, authority or tribunal or any subdivision thereof, and the authority/authorities
in each country in the Territory that have responsibility for granting regulatory approval for the Manufacture or Commercialization of
Product in each of such country, or for Pricing Approvals.


 






    9


     


    

 


1.92            “Regulatory
Exclusivity Period” means with respect to any country in the Partner Territory, a period of exclusivity (other than Patent
exclusivity), granted by Applicable Laws or by a Regulatory Authority in respect of such country, which either confers exclusive marketing
rights with respect to a product or prevents another party from using or otherwise relying on the data supporting the approval of the
Regulatory Approval for a product without the prior written authorization of the Regulatory Approval-holder, as applicable, such as new
chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent-related
pediatric exclusivity, or any other applicable marketing or data exclusivity, including any such periods under national implementations
in the EU of Article 8 of Directive 2001/83/EC, Article 14(11) of Parliament and Council Regulation (EC) No 726/2004,
Parliament and Council Regulation (EC) No 141/2000 on orphan medicines, Parliament and Council Regulation (EC) No 1901/2006
on medicinal products for pediatric use and all international equivalents.


 


1.93            “Regulatory
Requirements” means (a) all specifications, methods of Manufacture (or packaging, labelling or serialization) and other
information in one or more Regulatory Submissions related in any way to the Product, and (b) all Applicable Laws, applicable regulatory
guidance documents, and other requirements of any Regulatory Authority that govern the Product, including its Manufacture (or packaging,
labelling or serialization), including but not limited to the requirements set forth in Council Regulation (EC) No 726/2004, Directive 2001/83/EC
or any implementing or complementing national regulation, and the respective GMP Guidelines, and in each case, the foreign equivalents
thereof, as any of the foregoing may be amended from time to time.


 


1.94            “Regulatory
Submissions” means all applications, filings, briefing books, dossiers and the like submitted to a Regulatory Authority for
the purpose of obtaining Regulatory Approval or a Pricing Approval from that Regulatory Authority.


 


1.95            “Representatives”
has the meaning set forth in Article 8.4.


 


1.96            “Right
of First Negotiation” has the meaning set forth in Article 3.8(b).


 


1.97            “Royalty
Rate” has the meaning set forth in Article 6.3.


 


1.98            “Royalty
Term” has the meaning set forth in Article 6.4.


 


1.99            “Sales
Milestone Event” has the meaning set forth in Article 6.2(c).


 


1.100         “Sales
Milestone Payment” has the meaning set forth in Article 6.2(c).


 


1.101         “SmPC”
has the meaning set forth in Article 6.5(a).


 


1.102         “Stand-Still-Fee”
has the meaning set forth in Article 5.8(b).


 


1.103         “Supply
Agreement” has the meaning set forth in Article 5.1.


 






    10


     


    

 


1.104         “Tax”
or “Taxes” means any (a) all federal, provincial, territorial, state, municipal, local, foreign or other taxes,
imposts, rates, levies, assessments and other charges in the nature of a tax (and all interest and penalties thereon and additions thereto
imposed by any Governmental Authority), including all income, excise, franchise, gains, capital, real property, goods and services, transfer,
value added, gross receipts, windfall profits, severance, ad valorem, personal property, production, sales, use, license, stamp, documentary
stamp, mortgage recording, employment, payroll, social security, unemployment, disability, escheat, estimated or withholding taxes, and
all customs and import duties, together with all interest, penalties and additions thereto imposed with respect to such amounts, in each
case whether disputed or not; (b) any liability for the payment of any amounts of the type described in clause (a) as
a result of being or having been a member of an affiliated, consolidated, combined or unitary group; and (c) any liability for the
payment of any amounts as a result of being party to any tax sharing agreement or arrangement or as a result of any express or implied
obligation to indemnify any other person with respect to the payment of any amounts of the type described in clause (a) or
(b).


 


1.105         “Term”
has the meaning set forth in Article 12.1.


 


1.106         “Territory”
means (a) with respect to Partner, the Partner Territory and (b) with respect to Calliditas, the Calliditas Territory.


 


1.107         “Third
Party” means any Person other than Calliditas, Partner and their respective Affiliates.


 


1.108         “Unconditional
Regulatory Approval” means a Regulatory Approval granted in accordance with Art. 14 (1) Council Regulation (EC) No
726/2004.


 


1.109         “Valid
Claim” means, with respect to a particular country and the Product, (a) a claim of an issued and unexpired Licensed Patent
(other than a utility model or design right) that (i) has not been held permanently revoked, unenforceable or invalid by a decision
of a court or other governmental authority of competent jurisdiction, which decision is unappealable or unappealed within the time allowed
for appeal and (ii) has not been cancelled, withdrawn, abandoned, disclaimed or admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise, or (b) a claim which (i) is pending in a patent application included in the Licensed Patents
(other than an application for a utility model or design right) in such country less than [***] from the earliest date on which such
patent application claims priority, and (ii) has been prosecuted in good faith and has not been cancelled, withdrawn or abandoned
or finally rejected by an administrative agency action from which no appeal can be taken; and, in each case of such an issued or pending
claim pursuant to (a) or (b), [***].


 


Article 2


 


CLINICAL DEVELOPMENT AND REGULATORY APPROVAL


 


2.1            Ongoing
Clinical Trial. Calliditas shall, at its sole cost, complete the Ongoing Clinical Trial except
to the extent that it is not able to do so due to any safety issue or regulatory restriction or other circumstances outside the control
of Calliditas and its Affiliates. Notwithstanding the provisions of Article 2.9, Calliditas shall keep Partner informed of the status
and progress of the Ongoing Clinical Trial through the JSC. Calliditas shall provide to Partner all clinical study reports and related
documentation with respect to the Ongoing Clinical Trial and, notwithstanding the provisions of Article 3.5, any Know-How arising
in connection with the conduct of the Ongoing Clinical Trial as soon as practically possible.


 






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2.2            EMA
Marketing Authorization Application.


 


(a)            Calliditas
has, at its sole cost, submitted an application for Conditional Regulatory Approval, including an Orphan Designation maintenance report,
in the name of Calliditas in respect of the Product. Calliditas has used and will use Commercially Reasonable Efforts to obtain Conditional
Regulatory Approval and to maintain the Orphan Designation. Notwithstanding the provisions of Article 2.9, Calliditas shall keep
Partner informed of the status and progress of the MAA through the JSC.


 


(b)            For
the purposes of the MAA, Calliditas has, at its sole cost acquired access to an environmental risk assessment (“ERA”)
of the Product and provided this ERA data to the competent Regulatory Authority.


 


2.3            Transfer
of Conditional Regulatory Approval and Orphan Designation.


 


(a)            Promptly
after first grant of Conditional Regulatory Approval for the Product, Calliditas shall, at its sole cost, file with the EMA all documentation
necessary for the European Commission to transfer the rights and obligations related to being the market authorization holder in respect
of the Product in the territory under the jurisdiction of the EMA, to Partner. The Parties shall cooperate and promptly take all such
actions reasonably necessary or desirable, with each Party bearing its own expenses, in order to procure the prompt transfer of the same
to Partner. Notwithstanding any other provision of this Agreement: (i) Partner shall not market or sell the Product in the Partner
Territory prior to completion of such transfer to Partner, except where Partner may lawfully distribute the Product before such transfer,
in which case Calliditas will support Partner and take all necessary steps allowing Partner to assume the role of distributor; and (ii) Partner
shall not assign or transfer any Regulatory Approval other than (x) to an Affiliate of Partner (other than an Excluded Partner Affiliate)
or (y) where required by local laws to have the Product distributed by a distributor, to that distributor of Partner, and only for
so long as such entity remains an Affiliate or distributor of Partner. After the successful transfer of the transfer to Partner pursuant
to this Article of the rights and obligations related to being the market authorization holder, except as expressly set out in this
Agreement, Partner shall be solely responsible for the compliance with and performance of any and all obligations (including any regulatory
filings, updates and safety data reporting) related to being the market authorization holder in respect of the Product in the territory
under the jurisdiction of the EMA, irrespective of any assignments and transfers.


 






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(b)            Promptly
after grant of Conditional Regulatory Approval for the Product, Calliditas shall, at its sole cost, file with the EMA all documentation
necessary to transfer the Orphan Designation to Partner in accordance with Art. 5 (11) Council Regulation (EC) No 141/2000 on orphan
medicines. The Parties shall cooperate and promptly take all such actions reasonably necessary or desirable, with each Party bearing
its own expenses, in order to procure the prompt transfer of the Orphan Designation to Partner. Notwithstanding any other provision of
this Agreement, Partner shall not assign or transfer the Orphan Designation to any Third Party other than (x) to an Affiliate of
Partner (other than an Excluded Partner Affiliate) or (y) where required by local laws to have the Product distributed by a distributor,
to that distributor of Partner, and only for so long as such entity remains an Affiliate or distributor of Partner. After the successful
transfer of the Orphan Designation to Partner, except as expressly set out in this Agreement, Partner shall be solely responsible for
compliance with and performance of any and all obligations related to upholding the Orphan Designation or orphan status in the Partner
Territory.


 


(c)            [***].


 


2.4            Partner
Territory Regulatory Submissions. Partner shall, at its sole cost:


 


(a)            promptly
after issue by Calliditas of the final clinical study report in respect of the Ongoing Clinical Trial and after successful transfer of
the Conditional Regulatory Approval and the Orphan Designation to Partner, apply for Unconditional Regulatory Approval in respect of
the Product in the Field from the EMA; and


 


(b)            apply
Commercially Reasonable Efforts to make all filings and notifications in connection with, and obtain and maintain, all Pricing Approvals
in each country of the Partner Territory; and


 


(c)            after
issue by Calliditas of the final clinical study report in respect of the Ongoing Clinical Trial, use Commercially Reasonable Efforts
to obtain and maintain Regulatory Approval in each country of the Partner Territory in which approval of the MAA does not authorize sale
of the Product (including the United Kingdom and Switzerland).


 


2.5            Development
by Parties; Paediatric Investigation Plan.


 


(a)            Any
Development activities that are necessary to obtain and maintain Regulatory Approval for the Product in the Field in each country of
the Partner Territory, shall be thoroughly defined and divided between the Parties through the JSC (building on the significant preparations
already undertaken by Calliditas with regards to the design and execution of the PIP) provided that:


 


(i)            [***];
and


 


(ii)           [***].


 


(b)            Partner
agrees to cover any costs incurred by Calliditas in connection with conducting the PIP in the amount of up to [***]. Any additional PIP-related
costs, in particular resulting from a required change of the protocol, shall be subject to a cost sharing model and further discussed
between the Parties through the JSC.


 






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2.6            Clinical
Development by Partner. Notwithstanding any other provision of this Agreement, Partner (and
its Affiliates (other than Excluded Partner Affiliates) and Third Parties authorized or assisted by Partner) shall not conduct a Clinical
Trial without the prior written consent of Calliditas. Prior to seeking regulatory approval for or initiating any Clinical Trial or permitting
an Affiliate or Third Party to do so (whether before or after grant of Regulatory Approval of the Product), Partner shall notify Calliditas
of its intention (or that of Partner’s Affiliates or such Third Parties) to conduct a Clinical Trial, and provide a detailed synopsis
and protocol of such Clinical Trial to the Alliance Manager, CMO and CEO of Calliditas. Calliditas shall be deemed to have given its
consent to the conduct of a Clinical Trial in accordance with the provided protocol upon the expiry of thirty (30) Business Days after
receipt by Calliditas (as above) of the protocol unless Calliditas notifies Partner in writing during such period that consent is not
granted. Calliditas may withhold its consent to the conduct of a Clinical Trial in good faith on the grounds that the proposed Clinical
Trial [***].


 


2.7            Assistance
from Calliditas. Calliditas shall, at the reasonable request of Partner, provide to Partner
information (but excluding information relating to Manufacture of the Product) within the Control of Calliditas that is necessary for
Partner to prepare, file applications for, obtain and maintain Regulatory Approval for the Product as it exists at the Effective Date
in each country of the Partner Territory provided that, except as provided in Article 2.1 and 2.2, Calliditas shall not be obliged
to undertake any Development activities unless otherwise agreed by the Parties through the JSC.


 


2.8            Responsibility
for Regulatory Interaction. Except as otherwise set out in this Article 2, as between the
Parties (provided that Calliditas may have licensees in respect of the Product in the Calliditas Territory):


 


(a)            Partner
shall not take any action in connection with preparing, filing, obtaining and maintaining (x) Regulatory Approval for the Product
in the Calliditas Territory, and (y) the Orphan Designation or orphan status (where applicable) for the Product in the Calliditas
Territory;


 


(b)            Partner
shall have sole responsibility, at its own expense, (i) for maintaining the Conditional Regulatory Approval and Orphan Designation
or orphan status once transferred to Partner, and (ii) for preparing, filing, obtaining and maintaining in Partner’s name
all Regulatory Approvals (excluding the Conditional Regulatory Approval) and Pricing Approvals for the Product in the Partner Territory;


 


(c)            Without
limitation to any other obligations of Partner, Partner shall at its own expense:


 


(i)            take
all steps necessary or desirable in a timely manner to maintain and renew any Regulatory Approval, and Pricing Approval and the Orphan
Designation or orphan status in the Partner Territory; and


 


(ii)            fulfil
all obligations within all applicable timelines in connection with the Conditional Regulatory Approval (including, subject to Article 2.3(c),
completing ongoing or new studies (other than the Ongoing Clinical Trial)), collecting additional data to confirm the Products benefit-risk
balance remains positive, in each case as may be requested by any Regulatory Authority;


 






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(d)            Each
Party shall be responsible for all communications and other dealings with the Regulatory Authorities within its respective Territory
relating to the Regulatory Approvals and Pricing Approvals in its Territory; and


 


(e)            for
the avoidance of doubt, Partner shall be solely responsible for determining the prices for the Product in the Partner Territory, if and
to the extent not restricted by the Applicable Laws, [***].


 


2.9            Mutual
Cooperation.


 


(a)            As
soon as practically possible after receipt thereof, Calliditas shall provide material related to the regulatory review of Part A
of the Ongoing Clinical Trial, including with respect to the application for Conditional Regulatory Approval and the maintenance of the
Orphan Designation, to Partner and ask Partner to provide feedback. In essential communication with the Regulatory Authority or other
strategic decisions to be made by Calliditas in connection with the Ongoing Clinical Trial, Calliditas shall consider in good faith said
feedback provided by Partner, unless in particularly urgent cases where Calliditas cannot reasonably be expected to wait for such feedback.


 


(b)            Partner
shall, as marketing authorization holder, promptly notify Calliditas of all Regulatory Submissions, questions or enquiries as well as
any material correspondence that it receives or plans to submit to a Regulatory Authority and shall promptly provide Calliditas with
a full copy (which may be wholly or partly in electronic form) of the same. Promptly following receipt of any Regulatory Approval or
other decision on a Regulatory Submission from a Regulatory Authority relating to the Product, Partner also shall furnish Calliditas
with copies of the same (together with an English translation of the same, if applicable).


 


(c)            Partner
will keep Calliditas reasonably appraised of the status of any Regulatory Submissions related to the Product in the Partner Territory.
Partner shall promptly notify Calliditas in writing upon receipt of any Regulatory Approval with respect to the Product in the Partner
Territory. Partner will provide Calliditas with a report, not less than twenty (20) days after the end of each Calendar Quarter during
the Term, describing in reasonable detail the status of all Regulatory Submissions and any applications, filings or notices made in connection
with Pricing Approvals.


 


(d)            Each
Party shall, in connection with the other Party’s interactions with Regulatory Authorities with respect to the Product in the other
Party’s Territory, (i) provide to the other Party such data or information within the first Party’s control as is reasonably
necessary or useful for such interactions; and (ii) cooperate with the other Party’s reasonable requests related to such interactions
at the requesting Party’s cost.


 






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(e)            Each
Party shall notify the other Party of: in the case of Partner, the principal issues raised in each material communication with Regulatory
Authorities with respect to the Product; and in the case of Calliditas, the principal issues relevant to the activities of Partner under
this Agreement that are raised in each material communication with the FDA with respect to the Product, within fifteen (15) Business
Days after receipt thereof.


 


2.10            Regulatory
Meetings. Apart from the process related to obtaining Unconditional Regulatory Approval of the
Product, where specific processes will apply, Partner shall provide Calliditas with reasonable advance notice, including relevant documentation,
of all substantive meetings with the Regulatory Authorities in the Partner Territory pertaining to the Product, or with as much advance
notice as practicable under the circumstances. Partner otherwise shall use Commercially Reasonable Efforts to permit Calliditas to have,
at Calliditas’ expense, a representative of Calliditas attend, solely as a non-participating observer, substantive meetings with
the Regulatory Authorities within the Partner Territory pertaining to the Product; provided, however, that if required
by the Regulatory Authority or Partner and not requested by Calliditas, a representative of Calliditas shall attend such meeting and
Calliditas’ costs and expenses associated with such attendance shall be reimbursed by Partner. Partner shall promptly furnish Calliditas
with relevant pre meeting documentation and copies of minutes of all meetings with a Regulatory Authority relating to the Product.


 


2.11         Adverse
Event Reporting.


 


(a)            Subject
to Article 2.11(c), each Party shall be responsible for complying with all Regulatory Requirements and other legal requirements
governing adverse events in its Territory.


 


(b)            As
promptly as practicable following the Effective Date, but in no event later than sixty (60) days or such longer period as may be mutually
agreed by the Parties, thereafter, Partner and Calliditas will negotiate and agree upon safety data exchange procedures in a separate
and detailed pharmacovigilance agreement (the “Pharmacovigilance Agreement”) and Partner shall not in any event sell
or administer a Product to any human prior to the execution of the Pharmacovigilance Agreement. Such agreement will describe the coordination
of collection, investigation, reporting, and exchange of information concerning adverse events or any other safety problem of any significance,
procedures for participation in the global safety database, and product quality and product complaints involving adverse events, sufficient
to permit each Party and its Affiliates and partners or (sub-)licensees to comply with its legal obligations. The safety data exchange
procedures will be promptly updated if required by changes in legal requirements. In the event of any conflict or inconsistency between
this Agreement and the Pharmacovigilance Agreement with respect to: (i) safety-related matters, the Pharmacovigilance Agreement
shall prevail; and (ii) any other matter, this Agreement shall prevail.


 


(c)            Unless
otherwise agreed by the Parties, Calliditas shall be responsible, itself or through a designee, for maintaining any required global safety
database with respect to the Product.


 






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Article 3


 


GRANT OF RIGHTS


 


3.1            License
Grant by Calliditas. 


 


(a)           Subject
to the terms and conditions of this Agreement, Calliditas, on behalf of itself and its Affiliates, hereby grants to Partner and its Affiliates
(only for as long as they remain Affiliates of Partner and excluding Excluded Partner Affiliates):


 


(i)            an
exclusive, non-sublicensable license under the Licensed Intellectual Property solely to Commercialize (but excluding secondary packaging,
labeling and serialization) the Product and, if applicable, a Combination or Combined Dosage Therapy Product, in each case in the Field
in the Partner Territory; and


 


(ii)            a
non-exclusive, non-sublicensable license under the Licensed Intellectual Property to Develop, with respect to Improved Products only
subject to Article 3.9, the Product and, if applicable, a Combination or Combined Dosage Therapy Product in the Field in the Partner
Territory and through subcontractors in the Calliditas Territory (but not to conduct (aa) Clinical Trials without the consent of Calliditas
pursuant to Article 2.6, (bb) Manufacturing Development (unless permitted pursuant to Article 3.1(d)) and (cc) any activities
directed to obtaining Regulatory Approval for a Product or Combination or Combined Dosage Therapy Product in the Calliditas Territory);
and


 


(iii)           a
non-exclusive non-sublicensable license under the Licensed Intellectual Property to conduct secondary packaging, labeling and serialization
of Product purchased under or as permitted by the Supply Agreement and, if applicable, a Combination or Combined Dosage Therapy Product,
in the Field in the Partner Territory and through subcontractors in the Calliditas Territory.


 


Partner shall remain
responsible for the performance of its Affiliates under this Agreement and a breach of an obligation imposed on Partner hereunder as
a result of breach by one of its Affiliates, shall be deemed to be a breach by Partner.


 


(b)            Notwithstanding
the foregoing, the exclusive rights granted under Article 3.1(a) shall not prevent the Development or Manufacture or secondary
packaging, labeling or serialization of the Product or Combination or Combined Dosage Therapy Product by or on behalf of Calliditas or
its Affiliates or its partners or licensees, in the Partner Territory, or the conduct of supply chain activities in respect of the same
by or on behalf of Calliditas or its Affiliates or its partners or licensees, in the Partner Territory, for Commercialization outside
the Partner Territory.


 






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(c)            Notwithstanding
anything to the contrary, Partner shall have the right to engage Third Party (sub)contractors (including analytic laboratories, contract
manufacturers and distributors) in the Partner Territory and the Calliditas Territory in connection with permitted Development, Manufacture
or Commercialization of the Product and Combination or Combined Dosage Therapy Product in the Field in the Partner Territory for the
benefit of Partner and to grant to such Third Party (sub)contractors all sublicenses required by it to perform the subcontracted tasks
for the benefit of Partner, provided that (i) Partner shall ensure that such contractors are bound by legally binding and enforceable
agreements under which all right, title and interest in and to all New Partner IP is solely and exclusively owned by Partner; and (ii) Partner
shall remain responsible for the performance of such contractors under this Agreement and a breach of an obligation imposed on Partner
hereunder as a result of breach by one of its contractors, shall be deemed to be a breach by Partner.


 


(d)            Only
as set out in:


 


(i)            Article 3.1
of the Supply Agreement; or


 


(ii)           Article 12.5(b)(ii) of
this Agreement;


 


subject to the terms and conditions
of this Agreement, Calliditas, on behalf of itself and its Affiliates, hereby grants and agrees to grant to Partner and its Affiliates
(only for as long as they remain Affiliates of Partner and excluding Excluded Partner Affiliates) a non-exclusive, non-sublicensable
license under the Licensed Intellectual Property to Manufacture the Product and, if applicable, a Combination or Combined Dosage Therapy
Product, in each case in the Field in the Partner Territory or the Calliditas Territory, solely for Commercialization by Partner or its
Affiliates in the Partner Territory in accordance with the terms of this Agreement. The provision by Calliditas to Partner of access
to the Licensed Know-How relating to Manufacture of the Product, following grant of the licence pursuant to this Article 3.1(d) shall
be as set out in the Supply Agreement, it being understood that [***]. Should such Manufacturing technology transfer be triggered by
Article 12.5(b)(ii) of this Agreement, such Manufacturing technology transfer shall be initiated [***]. Should such Manufacturing
technology transfer be triggered by Article 3.1 of the Supply Agreement, it shall be conducted diligently by the parties in such
manner and at such point of time to enable, to the extent reasonably possible, Manufacturing of the Products on behalf of the Partner
or by its designee without interruption.


 


3.2           License
Grant by Partner


 


(a)            Partner,
on behalf of itself and its Affiliates (other than Excluded Partner Affiliates), hereby grants to Calliditas and its Affiliates a perpetual,
irrevocable, fully paid-up, sub-licensable (including through multiple tiers) a non-exclusive license under the New Partner IP and Partner’s
share in New Joint IP solely as necessary for Calliditas (and its Affiliates and its and their licensees (including through multiple
tiers) and contractors of the foregoing) to conduct (i) the Development, Manufacture and secondary packaging, labeling and serialization
in the Field in the Partner Territory and in the Calliditas Territory, and (ii) Commercialization in the Field in the Calliditas
Territory, in each of case (i) and (ii) above, of the Product (including any Improved Product, whether such is developed by
Calliditas, by Partner or jointly by both Parties); and provided that any such use is consistent with the grant of licenses to Partner
pursuant to Article 3.1, and without limitation to the provisions of Section 3.4(b).


 






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(b)            This
un-blocking license is granted by Partner solely for the purpose to procure Calliditas’ (and its Affiliates and its and their licensees
(including through multiple tiers) and contractors of the foregoing) freedom to operate with regard to the Product in the Field in the
Calliditas Territory. If Calliditas at any time wishes to exploit New Partner IP for any other purpose (e.g. for Development or Commercialization
of a Combination or Combined Dosage Therapy Product), or to convert a non-exclusive license granted by Partner to an exclusive license,
Calliditas shall request from Partner a respective license and in such event the Parties shall in good faith negotiate the terms of any
such license, including reasonable consideration payable by Calliditas for such license.


 


3.3            Rights
of Reference.


 


(a)            Calliditas
hereby grants to Partner and its Affiliates (other than Excluded Partner Affiliates), subject to the terms and conditions set forth in
this Agreement, a “Right of Reference” as that term is defined in 21 C.F.R. § 314.3(b) (or any other similar provision
under Applicable Law outside the US) to all regulatory documents, dossiers and filings Controlled by Calliditas or its Affiliates inside
and outside the Partner Territory that relate to the Product, provided that such right shall be for the sole purpose of enabling Partner
or its Affiliates (other than Excluded Partner Affiliates) to obtain and maintain Regulatory Approval with respect to the Product in
the Partner Territory in the Field.


 


(b)            Partner
hereby grants to Calliditas and its Affiliates and its partners and licensees in respect of the Product outside the Partner Territory,
subject to the terms and conditions set forth in this Agreement, a “Right of Reference” as that term is defined in 21 C.F.R.
 § 314.3(b) (or any other similar provision under Applicable Law outside the US) to all regulatory documents, dossiers and filings
by Partner or its Affiliates (other than Excluded Partner Affiliates) that relate to the Product, provided that such right shall be for
the sole purpose of enabling Calliditas and its Affiliates and its partners and licensees to obtain and maintain Regulatory Approval
with respect to the Product outside the Partner Territory.


 


(c)            Each
Party shall provide a signed statement to give effect to the rights granted in this Article 3.3, if requested by the other Party.


 


3.4            Negative
Covenants..


 


(a)            Partner
shall not, nor shall it cause or permit any of its Affiliates or any Third Party to (and shall procure that its Affiliates (other than
Excluded Partner Affiliates) do not and require in its agreements with its contractors to the extent they need to perform acts permitted
by, or to exploit rights granted under this Agreement that they do not), (i) use or practice, directly or indirectly, any Licensed
Intellectual Property for any purposes other than as expressly permitted by this Agreement; nor (ii) directly or indirectly conduct
any activities with respect to Product or a Combination or Combined Dosage Therapy Product (or Regulatory Approval of the same) outside
the Field, it being understood that Partner shall be entitled to conduct (x) Development activities other than Clinical Trials and
activities directed to obtaining Regulatory Approval both in the Partner Territory and in the Calliditas Territory to the extent provided
in Article 3.1(a)(ii) and (y) Clinical Trials only subject to Article 2.6, whether in the Partner Territory or in
the Calliditas Territory.


 






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(b)            During
the Term, Partner shall not, nor shall it cause or permit any of its Affiliates or any Third Party to (and shall procure that its Affiliates
(other than Excluded Partner Affiliates)do not and shall require in its agreements with its contractors to the extent they need to perform
acts permitted by, or to exploit rights granted under this Agreement that they do not) Commercialize any solely Developed Improved Product
or solely Developed Combination or Combined Dosage Therapy Product outside the Partner Territory unless it has first notified Calliditas
of its intent to do so at a meeting of the JSC and, should Calliditas so request by notice [***] after such JSC meeting, negotiate exclusively
with Calliditas in good faith for a period of at [***] regarding the grant to Calliditas of the exclusive right to conduct such Commercialization
in such portions of the Calliditas Territory as nominated by Calliditas. With regard to Improved Products or Combination or Combined
Dosage Therapy Products which are jointly developed by the Parties, the Parties shall agree on mutual rights, responsibilities and licenses
in accordance with Article 3.9.


 


(c)            Without
limiting the generality of Article 3.4(a), and subject to Article 3.9, Partner is entitled, either itself or through any of
its Affiliates or any Third Party, to promote, market, recommend, sell or supply or otherwise Commercialize Combination or Combined Dosage
Therapy Product in the Partner Territory following Regulatory Approval in the Partner Territory which has been approved by the relevant
Regulatory Authority in the Territory.


 


(d)           Without
limiting the generality of Article 3.4(a), Partner shall not, nor shall it cause or permit any of its Affiliates or any Third Party,
to (and shall procure that its Affiliates (other than Excluded Partner Affiliates) do not and shall require in its agreements with its
contractors that they do not) promote, market, recommend, sell or supply or otherwise Commercialize the Product or a Combination or Combined
Dosage Therapy Product as a combination package in which the same is co-packaged with other pharmaceutical products, devices, pieces
of equipment, components or substances for Commercialization.


 


(e)            The
rights granted under Article 3.1(a) do not include any right to Manufacture the Product and Partner and its Affiliates shall
not Manufacture the Product nor purchase the Product from any Third Party except to the extent separately agreed in writing by Calliditas
or as provided in Article 3.1(d).


 


(f)            Partner
shall not grant rights to any Third Party under the Licensed Intellectual Property to obtain or hold any Regulatory Approval with respect
to the Product, unless legally required in a given country of the Partner Territory to enable Partner to engage distributors for Commercialization
of Products in such particular country and in such event Partner shall procure that such Regulatory Approval is immediate assigned to
Partner in the event of termination of the rights of such distributor and in any event upon termination of this Agreement.


 






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3.5            Provision
of Licensed Know-How.


 


(a)            Promptly
after the Effective Date, but in no event later than [***] thereafter, Calliditas will provide to Partner, in the format in which it
is held by Calliditas or its Affiliates, access to or copies of Licensed Know-How in the possession of Calliditas or its Affiliates that
is necessary for Partner to engage in the activities provided for and perform its obligations under this Agreement and the Supply Agreement,
provided that no information relating to Manufacture of the Product shall be required to be provided pursuant to this Article 3.5.


 


(b)            During
the Term (but subject to Article 2.1), Calliditas shall provide to Partner full and prompt disclosure, but in no event less frequently
than semi-annually or otherwise upon request of Partner for good cause shown, of any Licensed Know-How (excluding Licensed Know-How relating
to Manufacture of the Product) that becomes Controlled by and into the possession of Calliditas or any of its Affiliates after the Effective
Date and that is necessary for Partner to conduct its activities or exercise its rights as contemplated hereunder. Subject to Article 2.1,
promptly after Calliditas or its Affiliates come into the possession and Control of Licensed Know-How required to be provided to Partner
hereunder during the Term, Calliditas will provide the same to Partner, in the format in which it is held by Calliditas or its Affiliates.


 


(c)            If
reasonably necessary or useful for further permitted Development or Commercialization of the Product in the Partner Territory, and solely
on request of Partner, Calliditas shall re-arrange, re-format, compile, correct, or otherwise undertake secondary review of any Licensed
Know-How to be provided by Calliditas to Partner hereunder so that it is sufficiently understandable and useable for a reasonable Third
Party in the position of Partner, whereby the FTE Cost of any such secondary review activities and all out-of-pocket costs shall be chargeable
by Calliditas to Partner and shall be paid by Partner upon receipt of an invoice. Such secondary review activities and shall only be
performed subject to the availability of necessary Calliditas personnel and only using methods and procedures used by Calliditas in the
ordinary course of business. In the event that Partner identifies any additional Licensed Know-How (excluding Licensed Know-How relating
to Manufacture of the Product) required to be provided by Calliditas and that has not been provided, Partner may provide notice to Calliditas
and Calliditas shall, if Calliditas agrees that such Licensed Know-How is required to be provided by Calliditas, provide such Licensed
Know-How to Partner within fifteen (15) Business Days.


 


(d)            The
transfer set forth in Article 3.5(a) shall occur in an orderly fashion and in a manner such that the value, usefulness and
confidentiality of the transferred Licensed Know-How are preserved in all material respects. Calliditas shall provide such further reasonable
consultation and assistance to Partner as reasonably requested by Partner in order to perfect the transfer set forth in Article 3.5(a).
Calliditas shall provide such further reasonable consultation and assistance to Partner free of charge until such consultation and assistance
provided by Calliditas exceeds a total amount of [***] hours of work. Any further consultation and assistance thereafter, shall be chargeable
by Calliditas to Partner at the FTE Cost and shall be performed subject to the availability of necessary Calliditas personnel and only
using methods and procedures used by Calliditas in the ordinary course of business.


 






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(e)            Partner
shall, promptly after Partner or its Affiliates has come into the possession of the same, provide to Calliditas all data and information
arising from Development activities in connection with the Product or Combination or Combined Dosage Therapy Product and all Know-How
within the New Partner IP.


 


(f)            Notwithstanding
the provisions of this Agreement, Calliditas shall not be obliged to provide information relating to the process used for coating of
beads used in the Product, nor other information related to the specifics of the Manufacturing of the Product, unless otherwise agreed
by the Parties in the Supply Agreement or pursuant to Article 3.1(d).


 


3.6            Third
Party In-Licenses. Calliditas shall be responsible for all payments associated with any agreements
related to the Licensed Intellectual Property that exist as of the Effective Date, except as otherwise agreed by Partner in writing.
In the event that, after the Effective Date, (a) Calliditas or its Affiliates acquire Control of Licensed Intellectual Property,
or (b) an entity (other than an Acquirer) becomes an Affiliate of Calliditas, which entity Controls Licensed Intellectual Property;
and, in either such event Calliditas or its Affiliate or such entity owes payments or is subject to other restrictions or obligations
in respect of such Licensed Intellectual Property, Calliditas shall notify Partner of the existence of such restrictions or obligations.
Partner shall have the right to decline a license under the applicable Licensed Intellectual Property or take such license, provided
that if Partner elects to take such a license, Partner be obliged to enter into a separate agreement with Calliditas or its Affiliates
sufficient to enable Calliditas and its Affiliates to comply with the applicable restrictions or obligations owed. Unless and until the
Partner elects to take such a license and executes such separate agreement with Calliditas or its Affiliates, the relevant Licensed Intellectual
Property shall be deemed to be excluded from the definitions of “Licensed Patents”, “Licensed Know-How” and “Licensed
Intellectual Property” for all purposes except this Article 3.6. Partner shall be responsible for all payments due to any
third party to the extent triggered (in whole or in part) by the grant of such license to Partner or exercise by Partner of such license;
provided that, with respect to Licensed Intellectual Property of which Calliditas or its Affiliates acquire Control by way of an in-license
after the Effective Date, Partner shall only be responsible for such payments in respect of such Licensed Intellectual Property if:


 


(a)            Calliditas
was not in breach of Article 10.2(n) as at the Effective Date with specific reference to the relevant Licensed Intellectual
Property; and


 






    22


     


    

 


(b)            where
such in-license relates only to Licensed Intellectual Property necessary or useful in the Partner Territory:


 


(i)            Calliditas
has informed Partner of the need of obtaining such in-license promptly upon Calliditas’ becoming aware of such need and, in any
event, as soon as reasonably possible after (or preferably prior to) commencing negotiations for such in-license with such Third Party
licensor;


 


(ii)            prior
to executing such license with the Third Party, Partner has not notified Calliditas that it wishes to obtain such necessary license from
the Third Party directly (rather than in form of a sublicense from Calliditas); and


 


(iii)            Partner
has been given the opportunity to join the negotiations on such in-license together with Calliditas from commencement of substantive
detailed negotiations onwards;


 


provided that the
foregoing provisions of this Article 3.6(b) shall not apply where such in-license covers Patents or Know-How other than solely
Patents and Know-How necessary or useful in the Partner Territory.


 


3.7           Trademarks.


 


(a)            As
of the Effective Date, Calliditas hereby agrees to transfer and assign, and to cause its Affiliates to transfer and assign, and hereby
transfers and assigns to Partner all worldwide right, title, and interest in, to and under the Calliditas Trademarks, whether registered
or not, and all related internet domain names and registrations, including those listed on Schedule 1. Partner herewith accepts such
transfer and assignment. With regard to registration, maintenance and prosecution of the Calliditas Trademarks Article 7.9 shall
apply. Notwithstanding the assignment of the Calliditas Trademarks or any other provision of this Agreement, Partner (and its Affiliates
and contractors) may use the Calliditas Trademarks (or corresponding trademarks worldwide) only on or in relation to the permitted Manufacture
and Commercialization of Products or Combination or Combined Dosage Therapy Products in the Territory for Commercialization in the Partner
Territory or, subject to Article 3.4(b), for Commercialization in the Calliditas Territory and shall not use the same on or in relation
to the manufacture or commercialization of any other products or outside the Partner Territory.


 


(b)            Calliditas
agrees to execute any and all further instruments, forms of assignment or other documents, and take such further actions, as Partner
may reasonably request, in order to perfect the allocation of Calliditas Trademarks in accordance with Article 3.7(a) and to
enable Partner to exercise its right to register, prosecute and maintain the Calliditas Trademarks as set forth in Article 7.9.
Calliditas shall grant to Partner all necessary powers of attorney to enable Partner to act in the name and on behalf of Calliditas towards
all competent trademark registries worldwide in order to effect the registration of transfer of ownership of the Calliditas Trademarks
or to prosecute and maintain the Calliditas Trademarks prior to registration of transfer of ownership.


 






    23


     


    

 


(c)            Neither
Party shall do, or omit to do, or permit to be done, any act that will or may weaken, damage or be detrimental to the Calliditas Trademarks
or the reputation or goodwill associated with the Calliditas Trademarks, or that may invalidate or jeopardize any registration of Calliditas
Trademarks (or corresponding trademarks worldwide), whereby the Parties acknowledge that the Calliditas Trademarks in the Calliditas
Territory may be invalidated for lack of use by Partner.


 


(d)            Calliditas
shall neither use the Calliditas Trademarks (or a confusingly similar trademark) for Products or in connection with the Commercialization
of the Products in the Calliditas Territory nor for products other than the Products nor as part of its company name, as special designation
of its business or enterprise or otherwise as a sign to distinguish its business or as part of an Internet domain name. Calliditas has
not granted and will not grant to any Third Party a right to use the Calliditas Trademarks for Products or Combination or Combined Dosage
Therapy Products or in connection with the Commercialization of the Products or Combination or Combined Dosage Therapy Products in such
other territories.


 


(e)            The
transfer and assignment of the Calliditas Trademark to Partner pursuant to this Article 3.7 shall not cause any obligation of Partner
to exploit the Calliditas Trademark in the Partner Territory. Partner shall at any time during the Term be permitted to use its own alternative
trademarks for the Commercialization of Products in the Partner Territory, subject to its diligence obligations. In the event that Partner
elects to Commercialize the Product in the Partner Territory under a new, own trademark (instead of any of the Calliditas Trademarks),
Partner shall notify Calliditas of such new trademark (name and design) no later than thirty (30) days prior to use of such own trademark.


 


3.8          Discussions
on New Indications.


 


(a)            [***].


 


(b)           [***].


 


(c)            [***].


 


3.9            Development
of Combination or Combined Dosage Therapy Products or Improved Products


 


[***]:


 


(a)            [***].


 


(b)           [***].


 


(c)            [***].


 


(d)           [***].


 


(e)            [***].


 






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Article 4


 


MANAGEMENT


 


4.1            Joint
Steering Committee. Within [***] days after the Effective Date, the Parties will establish a
joint steering committee to oversee the Development and Commercialization of the Product in the Partner Territory and, solely if and
to the extent relevant for Development or Commercialization of the Product in the Partner Territory, in the Calliditas Territory, and
to monitor and provide overall strategic oversight of the activities under this Agreement (the “JSC”).


 


(a)            Membership.
The JSC shall be composed of up to [***]members, with up to [***] members appointed by each Party. Promptly following the Effective Date
(and no later than [***] thereafter), each Party shall appoint its initial representatives to the JSC. Each Party may replace its JSC
representatives at any time upon written notice to the other Party. Calliditas will designate one of its representatives as the chairperson
of the JSC. The chairperson shall be responsible for scheduling meetings, preparing and circulating an agenda in advance of each meeting
(provided, that either Party may request to include a specific item on any such agenda), preparing and issuing minutes of each
meeting within thirty (30) days thereafter, revising such minutes to reflect timely comments thereon, and overseeing the ratification
of such revised minutes. The Parties shall also each appoint an alliance manager to serve as the primary point of contact for each Party
under this Agreement (the “Alliance Manager”). The Alliance Managers shall not be members of or have voting rights
at the JSC, but shall be required to attend the meetings thereof.


 


(b)            Meetings.
The first meeting of the JSC shall occur upon its establishment, hence no later than [***] after the Effective Date. Until completion
of the Ongoing Clinical Trial, the JSC shall meet at least on a monthly basis. The Parties shall endeavor to schedule monthly meetings
of the JSC at [***] in advance. Thereafter, the JSC shall meet a minimum of [***] times per year. The Parties shall endeavor to schedule
semiannual meetings of the JSC at least two (2) months in advance. At each meeting of the JSC, Partner shall provide the JSC with
an update regarding the work performed by or on behalf of itself with respect to the Commercialization of the Product in the Partner
Territory since the last meeting. Either Party may invite, at its cost, subject matter experts or other relevant personnel to attend
any meeting of the JSC, provided that such participants are bound under written obligations of confidentiality and non-use no less protective
of the Parties’ Confidential Information than those set forth in this Agreement. The JSC may meet in person or by audio or video
conference as its representatives may mutually agree.


 


(c)            Responsibilities.
The JSC may discuss, in particular but not limited to, the following matters:


 


(i)            [***];


 


(ii)           [***];


 


(iii)          [***];


 






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(iv)          [***];


 


(v)           [***];


 


(vi)          [***];


 


(vii)         [***];


 


(viii)        [***];


 


(ix)           [***];


 


(x)            [***];


 


(xi)           [***];
and


 


(xii)          [***].


 


4.2          Decision
Making; Authority. Following the reasonable consideration of comments by each Party’s
representative members, the JSC shall make its decisions by consensus, with each Party’s representatives collectively having one
(1) vote. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the
JSC and within the scope of its authority the representatives of the Parties on the JSC cannot reach consensus as to such matter, then
the Parties shall refer such Dispute to the Applicable Senior Officers for attempted resolution by good faith negotiations within [***]
after such referral is made. If the Applicable Senior Officers are unable to resolve the Dispute within the time allotted then (i) Calliditas
shall have the final decision-making authority with respect to any matter related to Clinical Trials conducted by or on behalf of Calliditas;
(ii) Partner shall have the final decision-making authority with respect to (x) any matter related to approved Clinical Trials
conducted by or on behalf of Partner in the Partner Territory and (y) any matter related to Commercialization of the Product in
the Partner Territory, without limitation of Partner’s diligence obligations under this Agreement.


 


4.3          General
Principles.


 


(a)            The
JSC have no authority beyond the specific responsibilities set forth in this Agreement with respect thereto. In particular, and without
limiting the generality of the foregoing, the JSC may not amend or modify the terms or provisions of this Agreement.


 


(b)            Each
Party shall ensure that its representatives to the JSC have appropriate expertise and authority to serve as members of such committee.
Meetings of the JSC shall be effective only if at least one representative of each Party is present or participating. Each Party shall
be responsible for all of its own expenses of participating in JSC meetings. Each Party shall use good faith and cooperative efforts
to facilitate and assist the efforts of the JSC.


 






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(c)            The
JSC shall continue to exist until the Parties mutually agree to dissolve it.


 


(d)            Each
Party undertakes that it shall provide copies of all material documents relating to the topics under the purview of the JSC to the Alliance
Manager of the other Party as promptly as reasonably practicable following the generation or receipt thereof.


 


Article 5


 


COMMERCIALIZATION


 


5.1            Manufacture
and Supply of Product. As of the Effective Date, the Parties have entered into a separate supply
agreement (the “Supply Agreement”), which Supply Agreement provides for the entry into a related quality agreement
(the “Quality Agreement”) pursuant to which Calliditas (itself or through its Affiliates or contractors) will supply
all of Partner’s (and its Affiliates’ and contractors’) requirements of Product.


 


5.2            Overview
of Commercialization. Subject to the terms and conditions of this Agreement, Partner shall be
solely responsible for the Commercialization of the Product in the Field in the Partner Territory.


 


5.3            Commercialization
Plan. As soon as reasonably feasible after the Effective Date, but in no event later [***] thereafter,
Partner shall provide to Calliditas an initial commercialization plan which represents the preliminary projections of Partner regarding
the Commercialization of the Product in the Partner Territory (the “Commercialization Plan”). No later than [***]
after the Effective Date and at least twice per calendar year thereafter, Partner shall propose to the JSC changes, revisions and updates
to the Commercialization Plan, provided that any material changes proposed by Partner and presented to the JSC shall be reasonable and
based on a rationale provided in reasonable detail to the JSC when proposed, and the Parties shall discuss any such proposal in good
faith, acting reasonably. The final determination as to what changes or revisions shall be made to the Commercialization Plan shall be
made by Partner following discussion at the JSC and Partner shall provide a final copy of such updated plan to Calliditas. The JSC shall
create a commercialization committee, which committee shall operate substantially in accordance with the terms of Article 4, to
consider, discuss and provide input into the Commercialization of the Product in the Partner Territory.


 


5.4           Efforts.


 


(a)           Partner
shall:


 


(i)            use
Commercially Reasonable Efforts to:


 


(A)            [***];
and


 


(B)            [***].


 


Partner may decide
based on the Commercially Reasonable Efforts to [***];


 






    27


     


    

 


(ii)            [***];


 


(iii)           exercise
its rights under this Agreement and perform its obligations under the Commercialization Plan in a professional manner, and in compliance
with all material aspects of such Commercialization Plan and the requirements of Applicable Laws;


 


(iv)           be
solely responsible for all costs and expenses associated with its Commercialization of the Product in the Partner Territory; and


 


(v)            [***].


 


(b)            [***].


 


5.5            Reporting.
Partner shall, at least once per Calendar Quarter from the Effective Date, provide to Calliditas a written report, in such form as may
be reasonably required by Calliditas after consultation through the JSC, detailing:


 


(a)            the
status and progress of Partner’s Development activities in each country of the Partner Territory;


 


(b)            a
summary of Partner’s proposed Development activities in the next Calendar Quarter with respect to the Product in each country of
the Partner Territory; and


 


(c)            a
description of Commercialization activities with reference to the Commercialization Plan for each country of the Partner Territory.


 


5.6            Booking
of Sales and Handling Returns.


 


(a)            As
between the Parties, each Party shall be solely responsible for booking sales of the Product sold in its Territory. Each Party may warehouse
the Product both inside and outside of such Party’s Territory, provided that any sales with respect to such Product occur
and are booked in such Party’s Territory.


 


(b)            As
between the Parties, each Party shall be solely responsible for handling all returns of any Product sold in its Territory, as well as
all aspects of Product order processing, invoicing and collection, distribution, inventory and receivables of Product sold in such Territory.


 


5.7            Ex-Territory
Sales; Export Monitoring.


 


(a)            Ex-Territory
Sales. Subject to Applicable Laws, neither Party shall engage in any advertising or promotional activities relating to the Product
directed primarily to customers or other buyers or users of such Product located outside of its Territory or accept orders for the Product
from or sell the Product into such other Party’s Territory for its own account, and, if a Party receives any order for the Product
in the other Party’s Territory, it shall refer such orders to the other Party, to the extent it is not prohibited from doing so
under Applicable Laws.


 






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(b)            Export
Monitoring. [***].


 


5.8           Non-Compete.


 


(a)            [***].


 


(b)           [***].


 


(c)            [***].


 


Article 6


 


PAYMENTS


 


6.1            Upfront
Payment. In consideration of the licenses and other rights granted hereunder, Partner shall
pay to Calliditas a non-refundable, non-creditable and not subject to set-off payment in the amount of twenty million Euros (EUR 20,000,000)
within thirty (30) days following the Effective Date subject to receipt of an invoice for the upfront payment from Calliditas.


 


6.2            Milestone
Payments.


 


(a)            Development
Milestone Payments. In consideration of the licenses and other rights granted hereunder, Partner shall pay to Calliditas the
non-refundable, non-creditable, and not subject to set-off milestone payments set forth below (each, together with the reimbursement
milestone payment described in Article 6.2(b), a “Development Milestone Payment”) upon the first achievement
by or on behalf of Partner or its Affiliates of each of the corresponding events (each, together with the reimbursement milestone event
described in Article 6.2(b), a “Development Milestone Event”). Partner shall notify Calliditas in writing promptly
after achievement of the applicable Development Milestone Event and shall pay the corresponding Development Milestone Payment within
forty-five (45) days after receipt of Calliditas’ invoice therefore. Each of the milestone payments set forth in this Article 6.2(a) is
payable only once upon the first achievement of such Development Milestone Event with the Product.


 


	Development
    Milestone Event	Development
    Milestone Payment
	Grant
    of Conditional Regulatory Approval and related maintenance of the Orphan Designation	[***]
	Grant
    of Unconditional Regulatory Approval and related maintenance of Orphan Designation	[***]


 






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(b)            Reimbursement
Milestone Payment. In consideration of the licenses and other rights granted hereunder, Partner shall pay to Calliditas a non-refundable,
non-creditable and not subject to set-off payment in the amount of [***] within [***] after the Product obtains a final reimbursement
amount (Erstattungsbetrag) based on price negotiations with the Federal Association of Statutory Health Insurance Funds (Spitzenverband
Bund der Krankenkassen) according to section 130b of Volume V of the German Social Insurance Code (Fünftes Buch
Sozialgesetzbuch) but no later than [***].


 


(c)            Sales
Milestone Payments. In consideration of the licenses and other rights granted hereunder, Partner shall pay to Calliditas the non-refundable,
non-creditable, and not subject to set-off milestone payments set forth below (each, a “Sales Milestone Payment”)
upon the first (first time and one time) achievement by or on behalf of Partner or its Affiliates of each of the corresponding events
with annual (not cumulative) Net Sales of a Product in the Partner Territory (each, a “Sales Milestone Event”). Partner
shall notify Calliditas in writing promptly after achievement of the applicable Sales Milestone Event and shall pay the corresponding
Sales Milestone Payment within [***]after receipt of Calliditas’ invoice therefore. Each of the milestone payments set forth in
this Article 6.2(c) is payable only once upon the first achievement of such Sales Milestone Event with annual (not cumulative)
Net Sales of the Product in a given year:


 


	Sales
    Milestone Event	Sales
    Milestone Payment
	Annual
    Net Sales for the Product in the Partner Territory reaches or exceeds [***]	[***]
	Annual
    Net Sales for the Product in the Partner Territory reaches or exceeds [***]	[***]
	Annual
    Net Sales for the Product in the Partner Territory reaches or exceeds [***]	[***]
	Annual
    Net Sales for the Product in the Partner Territory reaches or exceeds [***]	[***]


 


(d)            Until
Partner has made all of the payments set forth in Article 6.2, Partner shall include as part of its royalty report pursuant to Article 6.5(f) following
the end of each Calendar Year an affirmative statement for each threshold Net Sales amount set forth in Article 6.2 that the aggregate
Net Sales of Product in the Partner Territory for the previous Calendar Year did or did not exceed such threshold.


 






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6.3            Royalties.
During the Royalty Term, Partner shall pay non-refundable, non-creditable royalty payments to Calliditas with respect to the Net Sales
of the Product at the following rate, as such rate may be adjusted pursuant to Article 6.5 (“Royalty Rate”):


 


	Net Sales	Royalty
    Rates
	Where
    annual Net Sales for the Product in the Partner Territory fall below or reach [***]	[***]of
    Net Sales
	Where
    annual Net Sales for the Product in the Partner Territory exceed [***]	[***]of
    Net Sales


 


6.4            Royalty
Term. Royalties payable under Article 6.3 shall be payable on a country-by-country basis
during the period beginning on the date of the First Commercial Sale of the Product in such country and ending on the latest of (a) the
last to expire Valid Claim of the Licensed Patents (including Patents within the New Joint IP, unless otherwise agreed by the Parties)
Covering the Product in such country, (b) the expiration of the last Regulatory Exclusivity Period applicable to such Product in
such country, and (c) [***] of the First Commercial Sale after Regulatory Approval of such Product in such country; but in any event
no later than upon [***] of the First Commercial Sale of a Product anywhere in the Partner Territory (not necessarily in the particular
country) (the “Royalty Term”).


 


6.5          Royalty
Adjustments. The royalty payments due by Partner to Calliditas under this Agreement shall be
subject to the following cumulative royalty adjustments:


 


(a)            Royalty
Reduction upon [***] for the Product. During the Royalty Term and on a country-by-country basis, the Royalty Rate which would otherwise
be due in respect of the Net Sales of a Product pursuant to Article 6.3 shall be reduced by [***] if [***]. For example, if the
Royalty Rate is [***] of Net Sales at the time of this reduction, it shall be reduced by [***] to a Royalty Rate of [***].


 


(b)            Royalty
Reduction upon Expiry of Regulatory Exclusivity Period. During the Royalty Term and on a country-by-country basis, the Royalty Rate
which would otherwise be due in respect of the Net Sales of a Product pursuant to Article 6.3 shall be reduced by [***]upon expiry
of the Regulatory Exclusivity Period for such Product in such country, provided that such expiration is not due directly to any breach
of this Agreement by or on behalf of Partner or its Affiliates. For example, if the Royalty Rate is [***] of Net Sales at the time of
this reduction, it shall be reduced by [***] to a Royalty Rate of [***]; if the Royalty Rate is (already reduced to) [***] of Net Sales
at the time of this reduction, it shall be reduced by [***] to a Royalty Rate of [***]


 


(c)            Generic
Version Entry. During the Royalty Term and on a country-by-country basis, the Royalty Rate which would otherwise be due in respect
of the Net Sales of a Product pursuant to Article 6.3 shall be reduced by [***]beginning with the royalty payment for the first
Calendar Quarter commencing after unit sales of Generic Versions in such country exceed [***] of total unit sales of the combined unit
sales of Generic Versions and the Product in two consecutive Calendar Quarters (as reasonably determined by Partner on the basis of unit
sales data from IQVIA or another source of comparable reputation), provided however, that the Person holding Regulatory Approval for
such Generic Version (the marketing authorization holder) in such country is not Partner or its Affiliate or any distributor of them
in connection with the Commercialization under this Agreement.


 






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(d)            Royalty
Stacking. If, during the Royalty Term, Partner is required to make any payments (including any upfront payments, milestone payments
or royalties) to a Third Party in consideration (including as a result of settlement or dispute resolution) for any Patent, Know-How
or other intellectual property right (excluding trademarks or tradenames) that, in the reasonable discretion of Partner, is necessary
for Partner to Commercialize the Product in the Partner Territory in the Field, Partner may deduct from any royalty due on the Net Sales
of such Product under Article 6.3 [***]of any payments due by Partner to the Third Party licensor for such license.


 


(e)            Minimum
Royalties and Offsets. In no event shall any royalty due under Article 6.3 be reduced by more than [***] of the amount that
would otherwise be due after taking into account all adjustments and reductions applicable to such royalty pursuant to this Agreement
(“Minimum Royalties”). Any royalty adjustment amounts in a country that are not applied to reduce a royalty payment
in a reporting period in order to maintain the Minimum Royalties may be carried over by Partner and be used to offset royalty payments
due in any subsequent reporting period for the same country.


 


(f)            Royalty
Reports. For as long as royalties or other payments are due under this Article 6, Partner shall provide Calliditas with royalty
reports at the end of each calendar month. Partner shall provide to Calliditas, within [***] after the end of the calendar month (i) on
a country-by-country basis, the amount of gross sales invoiced by Partner or its Affiliates for the sale of such Product in such month,
deductions therefrom and royalties owed thereon; and (ii) the Net Sales in respect of such month and the annual Net Sales in respect
of such Calendar Year. Royalty payments for each calendar month will be due at the same time as such reports for such month, subject
to receipt of an invoice for the royalties from Calliditas.


 


(g)            True-up.
Where the royalty report in respect of a given calendar month reports that Net Sales in respect of such Calendar Year exceed [***], the
royalty payment pursuant to Article 6.5(f) made at the time of such report shall include the additional royalty due at the
higher rate in respect of Net Sales the subject of previous royalty reports in respect of such Calendar Year.


 


6.6            Payment
Method. All payments due under this Agreement to Calliditas shall be made by bank wire transfer
in immediately available funds to an account designated by Calliditas.


 


6.7            Other
Amounts Payable. With respect to any amounts owed under this Agreement by one Party to the other
for which no other invoicing and payment procedure is specified in this Agreement, the applicable Party will provide an invoice, together
with reasonable supporting documentation, to the other Party for such amounts owed and the owing Party will pay any undisputed amounts
within [***] of receipt of the invoice, and any disputed amounts owed by a Party will be paid [***] of resolution of the dispute.


 






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6.8          Taxes.


 


(a)            Notwithstanding
anything else in this Article 6.8, each Party shall solely bear and pay all Taxes imposed on such Party’s net income or gain
(in each case, however denominated) arising directly or indirectly from the activities of the Parties under this Agreement. All payments
due under this Agreement are exclusive of any VAT. In case that payments to be made hereunder are subject to VAT the paying Party shall
pay to the receiving Party an amount equal to such VAT, in addition to such payment and at the time when such payment is due. The receiving
Party shall reasonably promptly deliver, or shall procure that its relevant Affiliate shall reasonably promptly deliver, to the paying
Party a VAT invoice in respect thereof, if and to the extent required or permitted by Applicable Law.


 


(b)            Payments
made to Calliditas hereunder shall be made in the full amounts set forth herein, except for any withholding taxes required by Applicable
Law. If Partner is required pursuant to Applicable Law to withhold any amounts in respect of Taxes from payments made to Calliditas hereunder,
Partner shall (i) deduct or withhold such Taxes from the payment made to Calliditas, (ii) timely pay such Taxes to the proper
taxing authority, and (iii) send proof of payment to Calliditas within thirty (30) days following such payment. Accordingly,
Partner shall not be obliged to “gross-up” any payments due to such withholding or deductions. Each Party shall comply with
(or provide the other Party with) any certification, identification or other reporting requirements that may be reasonably necessary
in order for Partner to not withhold Tax or to withhold Tax at a reduced rate under an applicable bilateral income tax treaty. Each Party
shall provide the other with commercially reasonable assistance to enable the recovery, as permitted by Applicable Laws, of withholding
Taxes or similar obligations resulting from payments made under this Agreement.


 


6.9              Interest.
If either Party fails to make any payment due under this Agreement by the date upon which such payment is due (and such payment is not
subject to a good faith dispute with the full undisputed portion having been paid), then interest of [***] above the base interest rate
(according to sec. 247 German Civil Code (BGB)) p.a. shall accrue, or interest at the maximum rate permitted by Applicable Laws,
whichever is the lower, and such interest shall be paid when such payment is made.


 


6.10            Currency
Exchange. All amounts referred to in this Agreement are expressed in, and all payments to
Calliditas or to Partner, as applicable, hereunder will be payable in, Euros. Sales in the Partner Territory, for purposes of
determining the Net Sales amount shall be calculated using the exchange rate
published by the European Central Bank under
(https://www.ecb.europa.eu/stats/policy_and_exchange_rates/euro_reference_exchange_rates/html/index.en.html) or, if not available,
as otherwise mutually agreed in writing by the Parties.


 


6.11            Records.


 


(a)            Retention.
Partner shall keep, and shall cause its Affiliates to keep, (i) for at least five (5) years following the end of the Calendar
Year to which they pertain adequate books and records of accounting for the purpose of calculating all royalties and other amounts payable
to Calliditas under this Agreement, and (ii) for at least [***] following the end of the Calendar Year to which they pertain, other
books and records documenting Partner’s satisfaction of its obligations under Article 5.4. Such record keeping obligation
shall survive any expiration or termination of this Agreement for the time provided herein.


 






    33


     


    

 


(b)            Access
to Records and Audit. Subject to the other terms of this Article 6.11, Calliditas may audit the records referred to in Article 6.11(a).
Such audit shall be conducted (i) after at least [***] written notice from Calliditas, at the facility(ies) where the applicable
records are maintained and (ii) no more frequently than once in any Calendar Year. The audit shall be conducted by a nationally
recognized accounting firm selected by Calliditas and to whom Partner has no reasonable objections. The auditor will execute a written
confidentiality agreement with Partner that is substantially similar to the confidentiality provisions of Article 8 and limits the
disclosure and use of information obtained from such audit to authorized representatives of the Parties and the purposes under this Article 6.11.
The auditor will send a copy of their report to both Parties at the same time. In any event the auditor shall only share with Calliditas
the findings and not the underlying data. Calliditas shall be responsible for expenses for the audit, except that Partner shall reimburse
Calliditas for the cost of such audit if such audit reveals that payments made by Partner are less than [***] of the amount actually
owed for the period of the audit.


 


(c)            Underpayment.
If, as a result of any audit pursuant to Article 6.11(b), it is shown that the payments to Calliditas were less than the amount
that should have been paid pursuant to this Agreement, then Partner shall, within [***] after Calliditas’ demand therefor, pay
Calliditas the amount of such shortfall, increased by interest calculated as provided in Article 6.9.


 


Article 7


 


INTELLECTUAL PROPERTY


 


7.1            No
Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances
will a Party or any of its Affiliates, as a result of this Agreement, obtain any ownership interest, license or other right (whether
by implication, estoppel or otherwise) in or to any Know-How, Patents or other intellectual property rights of the other Party or any
of such other Party’s Affiliates, including tangible or intangible items owned, controlled or developed by the other Party or any
of such other Party’s Affiliates, or provided by the other Party or any of its Affiliates to the receiving Party or any of its
Affiliates at any time, pursuant to this Agreement. As between the Parties, Calliditas is and will remain be the sole and exclusive owner
(or, as applicable, co-owner) of and retains all right, title and interest in and to all Licensed Patents and Licensed Know-How.


 


7.2            Determination
of Inventorship. Inventorship for inventions and discoveries first made during the course of
the performance of activities under this Agreement will be determined in accordance with the applicable laws for determining inventorship.


 






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7.3          Ownership.


 


(a)            New
Calliditas IP. As between the Parties, Calliditas will solely and exclusively own all right, title and interest in and to all Improvements
(and Patents claiming inventions therein) conceived, discovered, developed, reduced to practice or otherwise made solely (as between
the Parties) by or on behalf of one or more of Calliditas, its Affiliates and licensees (other than Partner or its Affiliates) (the “New
Calliditas IP”) and all confidential information incorporated in such New Calliditas IP shall be deemed Confidential Information
of Calliditas.


 


(b)            New
Partner IP. As between the Parties, Partner will solely and exclusively own all right, title and interest in and to all Improvements
(and Patents claiming inventions therein) conceived, discovered, developed, reduced to practice or otherwise made, solely (as between
the Parties) by or on behalf of one or more of Partner and its Affiliates and contractors (the “New Partner IP”) and
all confidential information incorporated in such New Partner IP shall be deemed Confidential Information of Partner.


 


(c)            New
Joint IP.


 


(i)            As
between the Parties, both Parties will jointly own, all right, title and interest in and to all Improvements (and Patents claiming inventions
therein), conceived, discovered, developed, reduced to practice or otherwise made, jointly by or on behalf of both of the Parties (the
 “New Joint IP”). All within the New Joint IP shall be deemed to be the Confidential Information of both Parties.


 


(ii)            Unless
otherwise agreed by the Parties pursuant to Article 3.9 with respect to joint Development projects, each Party shall notify the
JSC about any New Joint IP upon such Party becoming aware thereof. Promptly upon JSC’s notification about New Joint IP, the JSC
shall determine whether or not such New Joint IP shall be kept confidential or whether any Patents claiming inventions in such New Joint
IP shall be filed, prosecuted or maintained in the Territory (in the name of both Parties or, if ownership in New Joint IP is allocated
to either of the Parties alone, in the name of such Party). If ownership in New Joint IP is allocated to either of the Parties alone,
such New Joint IP shall be deemed to become New Calliditas IP or New Partner IP as applicable.


 


(iii)           In
case that the JSC does not allocate ownership in New Joint IP to either of the Parties, the JSC shall determine the rights and responsibilities
for filing, prosecution and maintenance of the Patents within New Joint IP and in such case the Parties shall bear the costs jointly
in the proportions determined by the JSC. Neither Party may file a Patent claiming New Joint IP without the prior consent of the other
Party through the JSC.


 


7.4          Patent
Prosecution and Maintenance.


 


(a)            As
between the Parties, Calliditas will have (i) the exclusive right and the obligation (provided that Calliditas may be released from
such obligation pursuant to Article 7.4(b)), at its cost, to file, prosecute and maintain all Licensed Patents listed in Schedule
3 as at the Effective Date in the Major Market Countries in the Partner Territory; and (ii) the exclusive right (but not the obligation),
at its cost, to file, prosecute and maintain all Patents within the New Calliditas IP, and Licensed Patents in any other country. In
respect of the Licensed Patents listed in Schedule 3 as at the Effective Date in the Major Market Countries, Calliditas will provide
to Partner copies of all draft filings and material documents filed with, sent to or received from the relevant national patent offices
or other Governmental Authorities in the course of filing, prosecuting and maintaining such Patents, in the case of such filings and
such filed or sent documents, where reasonably possible in sufficient time to provide Partner with a reasonable opportunity to comment
thereon prior to their submission to the relevant national patent office or other Governmental Authority, and will consider in good faith
(but, for clarity, will have no obligation to incorporate) such comments where timely received. With regard to all other Patents for
which Calliditas has the first right to file, prosecute and maintain, Calliditas will provide to Partner (i) once a year in the
second Calendar Quarter, a description in reasonable detail of its patent prosecution and maintenance strategy and activities, and (ii) an
update on then-current activities in the fourth Calendar Quarter of each year (or promptly in the event of any significant unanticipated
development).


 






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(b)            Should
Calliditas decide that it is no longer interested in maintaining or prosecuting a Patent within the Licensed Patents, which Patent relates
to the Product, in any country of the Partner Territory, it will promptly advise Partner in writing, and Partner will have the right,
but not the obligation, to assume such prosecution and maintenance in the Partner Territory at its sole cost and expense. Calliditas
shall be released from its obligations under Article 7.4(a) with respect to such Patent twenty (20) Business Days after the
date of such notice. If Partner advises Calliditas, within twenty (20) Business Days of Partner’s receipt of such notice from Calliditas,
that Partner desires to assume the prosecution or maintenance of the applicable Patent at Partner’s expense, then Calliditas will
not so abandon or fail to prosecute or maintain such Patent and shall permit Partner to assume such responsibility. Where Partner decides
to make such assumption, the Patent for which Partner assumes the responsibility to file, prosecute and maintain (i) will continue
to be included in the definition of “Licensed Intellectual Property” for the purpose of the license granted under this Agreement,
but (ii) will no longer be included in the definition of “Valid Claim” for the purpose of determination of the Royalty
Term under this Agreement.


 


(c)            As
between the Parties, Partner will have the exclusive right (but not the obligation), at its cost, to file, prosecute and maintain all
Patents within the New Partner IP. Partner will provide to Calliditas copies of all draft filings and material documents filed with,
sent to or received from the relevant national patent offices or other Governmental Authorities in the course of filing, prosecuting
and maintaining the Patents within the New Partner IP (the “Partner Controlled Patents”), in the case of such filings
and such filed or sent documents, in sufficient time to provide Calliditas with a reasonable opportunity to comment thereon prior to
their submission to the relevant national patent office or other Governmental Authority, and will consider in good faith (but, for clarity,
will have no obligation to incorporate) such comments. Should Partner decide that it is not interested in filing or is no longer interested
in maintaining or prosecuting a Patent within or claiming New Partner IP which relates solely and exclusively to the Product, it will
promptly advise Calliditas in writing, and Calliditas will have the right, but not the obligation to assume, such filing, prosecution
and maintenance at its sole cost and expense. If Calliditas advises Partner, within twenty (20) Business Days of Calliditas’ receipt
of such notice from Partner, that Calliditas desires to assume the prosecution or maintenance of the applicable Patent at Calliditas’
expense, then Partner will not abandon or fail to prosecute or maintain such Patent and shall permit Calliditas to assume such responsibility.
Where Calliditas decides to make such assumption, Partner will promptly assign all of its rights, title and interests in and to the applicable
Patent to Calliditas, and such assigned Patent will, from and after the date of such assignment, (i) be deemed to be included in
the definition of “Licensed Intellectual Property” for the purpose of the license granted under this Agreement, but (ii) will
not be included in the definition of “Valid Claim” for the purpose of determination of the Royalty Term under this Agreement.


 






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7.5            Infringement
by Third Parties.


 


(a)            Notice.
Each Party will promptly report in writing to the other Party’s Alliance Manager any Competitive Infringement of which such Party
becomes aware.


 


(b)           Right
to Bring Suit.


 


(i)            Calliditas
will have the first right (but not the obligation), at its sole expense, and, as required to bring or maintain such suit (if legally
required in a given country in the name of Partner), using counsel of Calliditas’ choosing, to bring and control any action or
proceeding to abate any alleged or threatened Competitive Infringement in the Partner Territory by enforcing any Licensed Patent in the
Partner Territory. If Calliditas does not bring and continue pursuing an action or proceeding against, or otherwise take steps to abate
a Competitive Infringement in the Partner Territory within [***] following the notice of such an alleged Competitive Infringement, then
Partner will have the right to bring and control an action to enforce any Licensed Patent in the Partner Territory to abate such Competitive
Infringement at its sole expense and by counsel of its own choice provided that in the event of a counterclaim alleging the invalidity
or unenforceability of any Licensed Patent, as between the Parties, Calliditas shall have the right (without any obligation) to defend
any such action.


 


(ii)            Calliditas
will have the sole right (but not the obligation), at its sole expense, using counsel of Calliditas’ choosing to bring and control
any action or proceeding to abate any alleged or threatened Competitive Infringement in the Calliditas Territory.


 


(c)            Cooperation;
Settlement. For any action or proceeding brought by a Party under Article 7.5(b)(i) (the “Initiating Party”),
regardless of which Party brings such action or proceeding, the other Party (the “Non-Initiating Party”) shall cooperate
reasonably in any such effort, all at the Initiating Party’s expense, and the Parties shall reasonably cooperate to address new
facts or circumstances that come to light during the course of any such action or proceeding that may affect the need for one Party or
the other to participate in such action. The Non-Initiating Party agrees to join or be joined as a party to such action, at the Initiating
Party’s expense, if needed for the Initiating Party to bring or continue an infringement action hereunder. The Non-Initiating Party
shall, at its own expense and with its own counsel, have the right to observe and provide comments with respect to any action brought
by the Initiating Party under this Article 7.5 (which comments the Initiating Party shall consider in good faith but be under no
obligation to incorporate). Neither Party may settle an action or proceeding brought under this Article 7.5 in a manner that, or
knowingly take any other action in the course thereof that, (i) imposes any monetary restriction or obligation on or admit fault
of the other Party or (ii) adversely affects the value, scope or validity of, or otherwise adversely affects the other Party’s
rights under this Agreement to as applicable, the Licensed Intellectual Property (including, for Calliditas, the exploitation of such
Patents in the Calliditas Territory), in each case, without the written consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed.


 






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(d)            Recoveries.
Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery realized by Calliditas or Partner as
a result of any litigation under Article 7.5(b)(i) (whether by judgement, award or settlement), shall be distributed to the
Parties as follows: [***] .


 


7.6            Defense
of Licensed Patents. Each Party shall notify the other Party in the event that such Party becomes
aware of any threat or proceeding challenging the validity of the Licensed Patents and in such case Calliditas shall have the first right
(but not the obligation), at its sole expense, to control the defense of the Licensed Patent against such challenges. If Calliditas does
not take control of the defense of the Licensed Patent, within (x) [***] following the notice of challenge of the validity of the
Licensed Patent or (y) any shorter period legally applicable to defend such challenge, then Partner will have the right to control
such defense at its sole expense and by counsel of its own choice. With regard to cooperation, settlement and recoveries, Article 7.5(c) and
(d) shall apply accordingly.


 


7.7            Defense
of Alleged Infringement of Third Party Rights. Subject to Article 11, in the event that
any Third Party claims intellectual property infringement against the Partner or any of its Affiliates as a result of the use of the
Licensed Intellectual Property in the Partner Territory, the use of the New Partner IP, the Commercialization of Products in the Partner
Territory, Partner shall have the exclusive right and responsibility to defend any such claim brought against the Partner or its Affiliates.
Partner shall keep Calliditas regularly informed regarding the strategy and content of its defense and Calliditas may observe and provide
comments with respect to the same, which comments shall be considered by Partner in good faith. Partner shall be free to enter into any
settlement or other voluntary disposition of such claim, provided that any such settlement or other voluntary disposition that limits
the scope, validity or enforceability of the Licensed Intellectual Property or restricts the Development, Manufacturing, or Commercialization
of the Products in the Calliditas Territory, or admits fault or wrongdoing on the part of the Calliditas or its Affiliates or partners
in the Calliditas Territory, must first be approved in writing by Calliditas (such approval not to be unreasonably withheld, delayed
or conditioned). Calliditas shall be deemed to have given its approval to any such settlement or other voluntary disposition if it fails
to give notice to Partner that it either (a) approves or (b) rejects (giving reasonable details of the grounds relied on by
Calliditas to substantiate its decision to reject) such settlement or other voluntary disposition within [***] of receipt of a request
from Partner for its approval (such initial request to provide a copy of the proposed settlement or disposition and all other information
which Calliditas may reasonably require to consider the matter at hand).


 






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7.8            Patent
Extensions. With respect to any election for patent term extension, supplemental protection
certificate or any of their equivalents with respect to the Licensed Patents or Patents within New Calliditas IP, Calliditas will have
the sole and exclusive right (but not the obligation) to seek such extensions in the Partner Territory at Calliditas’ sole cost
and expense. Upon the written request by Calliditas, Partner will reasonably cooperate with the implementation of such decisions. Calliditas
shall consider reasonably and in good faith requests from Partner with respect to such extensions in the Partner Territory. If Calliditas
confirms in writing to Partner that it does not intend to seek any such extensions in the Partner Territory, Partner may seek such extensions
in the Partner Territory at Partner’s sole cost, in Calliditas’ name.


 


7.9            Trademarks.


 


(a)            Upon
the transfer and assignment of Calliditas Trademarks pursuant to Article 3.7, Partner shall have:


 


(i)             the
sole right and the obligation, at Partner’s expense, to undertake Commercially Reasonable Efforts to prosecute and maintain the
Calliditas Trademarks in all territories covered by the Calliditas Trademarks as at the Effective Date;


 


(ii)            the
sole right (but not the obligation) to register, maintain and prosecute trademarks corresponding to the Calliditas Trademarks in other
territories in the Partner Territory and in the Calliditas Territory at its sole cost and expense.


 


(b)            Calliditas
shall notify Partner without undue delay if it becomes aware of any infringement of the Calliditas Trademarks in the Partner Territory
or the Calliditas Territory, in particular, if Calliditas becomes aware that a Third Party registers or uses a designation as a trademark
which is confusingly similar to the Calliditas Trademarks. Partner shall have the sole right, but not the obligation, to defend the infringement
at its sole cost and expense.


 


(c)            If
the existence of the Calliditas Trademarks in the Partner Territory or the Calliditas Territory is challenged by Third Parties by way
of cancellation actions or requests for cancellation or otherwise, or if claims are asserted against Partner by a Third Party for use
of the Calliditas Trademarks, the defense against these shall be exclusively reserved to Partner, unless Calliditas is obliged by Applicable
Laws to participate in the dispute as a party to the proceeding. In any event, Calliditas shall use its Commercially Reasonable Efforts
to assist Partner. Any costs incurring from such dispute, including Calliditas’ costs in providing such assistance, shall be borne
by Partner.


 






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Article 8


 


CONFIDENTIALITY AND DATA PROTECTION


 


8.1            Definition
of Confidential Information. During the Term, either Party (the “Disclosing Party”)
or its Affiliates may from time to time furnish the other Party (the “Receiving Party”) or its Affiliates with scientific,
technical, trade or business information or materials which are treated by the Disclosing Party as confidential or proprietary, including,
without limitation, information and materials related to, the Product, processes, formulae, procedures, tests, equipment, data, batch
records, reports, know-how, sources of supply, patent positioning, relationships with consultants and employees, business plans and business
developments, and information concerning the existence, scope or activities of any research, design, development, Manufacturing, marketing
or other projects. All such information shall be referred to herein as “Confidential Information”. “Calliditas
Confidential Information” means any and all Confidential Information for which Calliditas is the Disclosing Party and Partner
the Receiving Party hereunder or that is otherwise attributed to Calliditas pursuant to this Agreement. “Partner Confidential
Information” means any and all Confidential Information for which Partner is the Disclosing Party and Calliditas the Receiving
Party hereunder or that is otherwise attributed to Partner pursuant to this Agreement.


 


8.2            Confidentiality
and Duration of Confidentiality Obligations. Except (a) to the extent otherwise expressly
authorized by this Agreement, or (b) as otherwise agreed in writing by the Parties, the Receiving Party shall keep confidential
and shall not publish or otherwise disclose and shall not use for any purpose any Confidential Information of the Disclosing Party. Unless
otherwise provided for in this Agreement, the Parties’ obligations of confidentiality, non-disclosure and non-use set forth in
this Article 8 shall survive any expiry or termination of this Agreement for a period of ten (10) years after the effective
date of a termination or date of expiry.


 


8.3            Exclusions.
Notwithstanding anything herein to the contrary, the obligations of confidentiality and non-use under this Article 8 applicable
to Confidential Information hereunder shall not apply to information that:


 


(a)            at
the time of disclosure, is known publicly or thereafter becomes known publicly through no fault of the Receiving Party or anyone to whom
the Receiving Party has disclosed the Disclosing Party’s Confidential Information;


 


(b)            is
disclosed to the Receiving Party or its Representatives on a non-confidential basis by a Third Party that is not subject to any confidentiality
obligations to the Disclosing Party with respect to such information;


 


(c)            was
developed by the Receiving Party or its Representatives without use or knowledge of the Disclosing Party’s Confidential Information,
as shown by the Receiving Party’s or its Representatives’ prior written records;


 






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(d)            was
already known to the Receiving Party or its Representatives on a non-confidential basis before receipt from the Disclosing Party, as
shown by the Receiving Party’s prior written records (provided that this shall not relieve Partner of its obligation with respect
to Know-How within the New Partner IP); or


s


(e)            is
released with the prior written consent of the Disclosing Party (subject to the terms and conditions, if any, set out in the applicable
consent).


 


8.4          Permitted
Disclosures. Notwithstanding the foregoing, each Receiving Party may disclose the Disclosing
Party’s Confidential Information:


 


(a)            to
the Receiving Party’s or its Affiliates’ employees, directors, consultants, financial and other advisors, agents, and contractors
(but not, as concerns Partner, to Excluded Partner Affiliates except to selected personnel of Excluded Partner Affiliates in course of
applicable governance and steering proceedings (e.g. under a domination agreement)) and in the case of Calliditas not to its actual and
potential licensees (except where required to specify the scope of intellectual property rights Controlled by Calliditas under any such
actual and potential license agreement) (“Representatives”), who, in each case, are bound by obligations relating
to confidentiality at least as restrictive of those contained herein and who have a need to know such information in connection with
the Receiving Party’s performance of its obligations or practice of its licenses and other rights under this Agreement; provided,
however, that each Party will remain responsible for any act or omission by its Representatives which would, if effected by a Party,
constitute a breach of this Article 8,


 


(b)            to
Regulatory Authorities in connection with any Regulatory Submissions required for development or commercialization of Product or compliance
with Regulatory Requirements (i) in the case of Partner as Receiving Party, in the Partner Territory only; and (ii) in the
case of Calliditas as Receiving Party, in the Calliditas Territory only,


 


(c)            to
any actual or potential acquirer, merger partner, underwriter, investor, lender or other provider of financing, in each case in respect
of the Receiving Party, and the employees, directors, agents, consultants and advisors of any such Third Party, provided that they have
entered into legally binding written obligations relating to confidentiality at least as restrictive of those contained herein (but of
duration customary in confidentiality agreements entered into for a similar purpose);


 


(d)            in
the case of Partner to its subcontractors (including analytic laboratories or distributors) engaged in the permitted Development, Manufacture
or Commercialization of the Products in the Field in the Partner Territory, who, in each case, are bound by obligations relating to confidentiality
at least as restrictive of those contained herein and who have a need to know such information in connection with the Partner’s
performance of its obligations or practice of its licenses and other rights under this Agreement; provided, however, that Partner will
remain responsible for any act or omission by its subcontractors which would, if effected by Partner, constitute a breach of this Article 8;
or


 






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(e)            pursuant
to Articles 8.5 and 8.6 or upon prior written approval of the other Party.


 


8.5            Terms
of Agreement. The Parties agree that the terms of this Agreement will be considered Confidential
Information of both Parties. Subject to Articles 8.4 and 8.6 and except as set forth below, no Party shall, without the prior written
consent of the other Party, disclose in any manner to any Third Party the terms of this Agreement, except for terms or subject matter
which has been the subject of prior public disclosure or has been mutually approved by the Parties in writing for such disclosure. Each
Party acknowledges that the other Party may be legally required to file this Agreement as an exhibit to its filings with an applicable
securities regulator (for example, as may pertain to the United States Securities and Exchange Commission or Swedish Finansinspektionen),
subject to customary and legally permitted redaction of Confidential Information of the other Party. In addition: (a) either Party
may disclose such terms as are required to be disclosed in its publicly-filed financial statements or other public statements, pursuant
to Applicable Laws and stock exchange rules (e.g., the rules of the United States Securities and Exchange Commission, Nasdaq
Stockholm, or any other stock exchange on which securities issued by either Party may be listed); provided that, such Party shall,
to the extent permitted and if feasible in light of applicable time constraints, provide the other Party with a copy of the proposed
text of such statements or disclosure (including any exhibits containing this Agreement) sufficiently in advance (to the extent possible)
of the scheduled release or publication thereof to afford such other Party a reasonable opportunity to review and comment upon the proposed
text (including redacted versions of this Agreement), (b) either Party shall have the further right to disclose the terms of this
Agreement under a confidentiality obligation no less protective than those set forth in this Agreement (but of duration customary in
confidentiality agreements entered into for a similar purpose), to any actual or potential sublicensee, strategic partner, collaborator,
acquirer, merger partner, underwriter, investor, lender or other provider of financing, and the employees, directors, agents, consultants
and advisors of any such Third Party, and (c) each Party shall have the right to disclose information regarding the Development
or Commercialization status of the Product in their respective Territory to the extent such disclosure is required by Applicable Laws.


 


8.6           Mandatory
Disclosure.


 


(a)            Notification
and Consultation. In the event that the Receiving Party is required by applicable statute or regulation or by court order or judicial
or administrative process to disclose any part of the Disclosing Party’s Confidential Information (including material terms or
conditions of this Agreement), the Receiving Party shall to the extent permitted (i) promptly notify the Disclosing Party (if feasible
in light of applicable time constraints) of each such requirement and identify the documents so required thereby, so that the Disclosing
Party may seek or request the Receiving Party to seek an appropriate protective order, confidential treatment or other remedy or waive
compliance by the Receiving Party with the provisions of this Agreement and (ii) if feasible in light of applicable time constraints,
consult with the Disclosing Party on the advisability of taking legally available steps to resist or narrow the scope of such requirement.


 






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(b)            Limited
Disclosure. If, in the absence of such a protective order, confidential treatment request, other remedy or waiver by the Disclosing
Party regarding a disclosure pursuant to Article 8.6(a), the Receiving Party is nonetheless required to disclose any part of the
Disclosing Party’s Confidential Information or any material terms or conditions of this Agreement, the Receiving Party may disclose
such Confidential Information or material terms or conditions without liability under this Agreement, except that the Receiving Party
shall furnish only that portion of the Confidential Information or material terms or conditions that is legally required.


 


8.7            Data
Protection.


 


(a)            The
Parties acknowledge and agree to comply with all applicable data protection rules and legislation, including the GDPR and the regulations
on the doctor-patient confidentiality.


 


(b)            Each
Party agrees that personal data will only be processed as far as is necessary for the purposes of this Agreement, and only on a lawful
basis as set forth in Articles 6 and Article 9 GDPR. To the extent that the processing and use of either Party’s data,
in particular health data, requires the patients’ prior consent, the respective Party will be responsible to obtain such consent.


 


(c)            Should
any processing within the context of this Agreement be considered a processing under joint control pursuant to Article 26 GDPR,
the Parties shall enter into a separate joint control agreement according to Article 26 GDPR.


 


(d)            Insofar
as pursuant and in connection with this Agreement the Parties transfer personal data to their Affiliates or to Third Parties, the Parties
shall ensure that, by taking all appropriate measures, they comply with the applicable data protection and data secrecy laws. In particular,
each Party agrees that it will process personal data outside of the EEA only if and to the extent in compliance with Articles 44
et seqq. GDPR. To ensure that the rights of the data subjects under this Agreement are not compromised when personal data are processed
outside the EEA, the Parties agree to enter into standard contractual clauses or any other required data protection agreement. In doing
so, the Parties also consider the Schrems II decision of the European Court of Justice according to which, although standard contractual
clauses are still generally considered sufficient to protect personal data of EEA data subjects in compliance with the GDPR, a case-by-case
assessment of the data protection standards provided in the destination jurisdiction is required.


 


Article 9


 


PUBLIC ANNOUNCEMENTS; USE OF NAMES


 


9.1            Public
Announcements. The Parties agree that the public announcement of the execution of this Agreement
shall be substantially in the form of each Party’s respective press release attached hereto as Schedule 4, and the
Parties will cooperate in the release of such press releases promptly after the Effective Date (and neither Party shall make any other
statement to the public regarding the execution or any other aspect of the subject matter of this Agreement, except to the extent expressly
permitted under this Agreement, including without limitation, pursuant to Article 8.5). Either Party may use the text of a statement
previously approved by the other Party in subsequent public announcements.


 






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9.2            Use
of Names. Neither Party shall make use of the name of the other Party or any of its Affiliates
in any advertising or promotional material, or otherwise, without the prior written consent of such other Party, except as permitted
pursuant to Article 9.1 or Article 8. Notwithstanding the foregoing, either Party may use the name of the other Party or its
Affiliates in the context of mentioning the existence of this Agreement in advertising or promotional materials or other materials required
to be filed in accordance with applicable securities laws, or as required by any Governmental Authority or Regulatory Authority, including
in conjunction with the Commercialization of the Product.


 


9.3            Publications.
Each Party shall use Commercially Reasonable Efforts to provide to the other Party drafts of publications regarding the Product sufficiently
in advance of their submission to provide a reasonable opportunity for comment and discussion between the Parties, and for the removal
of any Confidential Information of such other Party, and such Party shall consider in good faith any such comments; provided, however,
that, except as otherwise provided in this Agreement, such Party shall not be obligated to incorporate any such comments into such publications.
Partner shall include a customary acknowledgment of Calliditas as the licensor of the Product in any publications by or on behalf of
Partner. Nothing in this Article 9.3 grants to either Party any right to publish the Confidential Information of the other Party
(even if the other Party has had the opportunity to review the proposed publication) and the provisions of this Article 9.3 are
without prejudice to the provisions of Article 8.


 


Article 10


 


REPRESENTATIONS, WARRANTIES AND COVENANTS


 


10.1         Mutual
Representations and Warranties of Calliditas and Partner. Each of Partner, on behalf of itself
and its Affiliates (other than Excluded Partner Affiliates), and Calliditas, hereby represents and warrants to the other Party as of
the Effective Date as follows:


 


(a)            It
is duly organized and validly existing under the laws of the jurisdiction of its incorporation or formation, as applicable.


 


(b)            It
has the requisite corporate power and authority to conduct its business as presently being conducted and as proposed to be conducted
by it.


 


(c)            All
corporate actions on its part, necessary for (i) the authorization, execution, delivery and performance by it of this Agreement,
and (ii) the consummation of the transactions contemplated hereby, have been duly taken and it has the requisite corporate power
and authority to enter into this Agreement and to perform its obligations contemplated hereunder.


 






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(d)            This
Agreement constitutes a valid and binding obligation, enforceable against it in accordance with its terms (except in all cases as such
enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws affecting the enforcement
of creditors’ rights generally and except that the availability of the equitable remedy of specific performance or injunctive relief
is subject to the discretion of the court or other tribunal before which any proceeding may be brought).


 


(e)            The
execution, delivery and performance of this Agreement, and compliance with the provisions of this Agreement, by such Party do not and
will not: (i) violate any provision of any Applicable Laws or any ruling, writ, injunction, order, permit, judgment or decree of
any Governmental Authority, (ii) constitute a breach of, or default under (or an event which, with notice or lapse of time or both,
would become a default under) or conflict with, or give rise to any right of termination, cancellation or acceleration of, any agreement,
arrangement or instrument, whether written or oral, by which such Party or any of its assets are bound, or (iii) violate or conflict
with any of the provisions of such Party’s organizational documents (including any articles or memoranda of organization or association,
charter, bylaws or similar documents).


 


(f)            Apart
from expiration or termination of any applicable waiting periods (including any extensions thereof) required by any Applicable Laws or
governmental entity for antitrust purposes in the Territory, there are no filings, consents, approvals, authorizations or other orders
of, or notice to, any Governmental Authority or other Third Parties that are necessary to be obtained or made by such Party in connection
with the authorization, execution and delivery by such Party of this Agreement.


 


(g)            To
such Party’s knowledge, neither it nor its officers, employees, agents, consultants or any other person used by such Party in the
performance of the respective activities under this Agreement is: (i) debarred or disqualified under the FD&C Act; (ii) listed
by any government or regulatory agencies as ineligible to participate in any government healthcare programs or government procurement
or non-procurement programs (as that term is defined in 42 U.S.C. § 1320a-7b(f)), or excluded, debarred, suspended or otherwise
made ineligible to participate in any such program; or (iii) convicted of a criminal offense related to the provision of healthcare
items or services, or is subject to any such pending action.


 


10.2         Additional
Representations and Warranties of Calliditas. Calliditas hereby further represents and warrants
to Partner, as of the Effective Date, that except as set forth on Schedule 5:


 


(a)            Calliditas
is solvent and has the ability to pay and perform all of its obligations as and when such obligations become due, including payment obligations
and other obligations under this Agreement.


 


(b)           Schedule 3
contains a true, complete and accurate list of all Patents Controlled by Calliditas that (i) [***]; and (ii) [***].


 






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(c)            To
Calliditas’ knowledge (without having made any specific enquiry) and except as specifically disclosed by Calliditas in writing,
there are no Patents, Know-How or other intellectual property rights of Calliditas, its Affiliates or Third Parties Covering (with respect
to Patents) or otherwise claiming or protecting (with respect to Know-How or other intellectual property rights) the composition of matter,
method of use, dosing, Manufacturing or formulation of the Product that [***].


 


(d)            the
Licensed Patents set forth on Schedule 3 are in full force and effect and have been maintained to date.


 


(e)            Calliditas
has sufficient legal or beneficial title and ownership of, or sufficient rights under, the Licensed Intellectual Property to grant the
licenses and other rights granted under such Licensed Intellectual Property to Partner pursuant to this Agreement, and, prior to the
Effective Date, Calliditas has not granted any assignment options, pre-emptive or other rights to any Third Party that, if exercised
by such Third Party, would conflict with the rights granted to Partner under this Agreement and neither Calliditas nor its Affiliates
have abandoned the Licensed Patents or otherwise allowed them to lapse.


 


(f)            None
of the Licensed Intellectual Property is Controlled by Calliditas pursuant to an in-license agreement.


 


(g)           To
Calliditas’ knowledge, the development, conception and reduction to practice of any and all Licensed Intellectual Property have
not misappropriated trade secrets, Patents, Know-How or other intellectual property rights or property of any Third Party.


 


(h)            Calliditas
is fully able to comply with its obligations concerning Data Protection as set forth in Article 8.7.


 


(i)            All
post-approval commitments to the Regulatory Authorities related to the Conditional Regulatory Approval are set out in full in Schedule 6.


 


(j)             The
Clinical Trials relating to the Product conducted or sponsored by or on behalf of Calliditas or its Affiliates have not violated the
Applicable Laws and, to the extent applicable, the Good Clinical Practice (GCP) determined by the International Conference on Harmonization
of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in such a way that this would materially impact the
grant of Conditional Regulatory Approval of the Product, or subsequent Unconditional Regulatory Approval of the Product. No Clinical
Trial has been terminated or suspended prior to its natural completion, and in case of any study which is ongoing as at the Effective
Date, there are to the best of the Calliditas’ knowledge, no circumstances which are likely to result in such early termination
or suspension.


 


(k)            The
pharmaceutical dossiers of the Product have not violated generally accepted pharmaceutical principles or the current state of science
and technology in such a way that this would materially impact the grant of the Conditional Regulatory Approval of the Product, or subsequent
Unconditional Regulatory Approval of the Product.


 






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(l)             Partner
will have direct access to original data, the processes applied in the Clinical Trial and the “Essential Documents” as defined
in ICH E6 (R2) provided that no access will be given to descriptions of the process used for coating of beads used in the Product nor
other information related to the specifics of the manufacturing of the Product, and provided that the data arising from the Ongoing Clinical
Trial will be made available only after the publication of the top line results of the Ongoing Clinical Trial.


 


(m)           There
is no (i) pending, or, to the knowledge of Calliditas, threatened, claim, interference, opposition, demand, suit, proceeding, arbitration
or investigation by a Governmental Authority of a civil, criminal or regulatory nature against Calliditas, or (ii) judgment or settlement
against or owed by Calliditas, in each case of the immediately foregoing (i) and (ii), in connection with the Licensed Intellectual
Property, including any Third Party challenging the ownership, validity or scope of any Licensed Intellectual Property.


 


(n)            To
the knowledge of Calliditas (without having made any specific enquiry), the Commercialization of the Product in the Partner Territory
will not infringe any existing issued Patent of any Third Party. Calliditas has not received any written notification from a Third Party
that Commercialization of the Product infringes or misappropriates the Patents, Know-How or other intellectual property rights owned
or otherwise controlled by such Third Party in the Partner Territory; there are no pending litigation, claims, judgments or settlements
against Calliditas in respect of the Partner Territory or amounts due with respect any such claims and, to Calliditas’ knowledge,
no Third Party has any basis for any such claim.


 


(o)            Calliditas
has no actual knowledge that any Third Party is infringing or misappropriating the Licensed Intellectual Property in the Partner Territory
and there are no pending litigation, claims, judgments or settlements against any Third Party or amounts due with respect any such claims.


 


(p)            All
information, documentation and other materials made available by Calliditas during the period of diligence prior to the Effective Date
were provided in good faith, and are, to the best of Calliditas’ knowledge, accurate and complete in all material respects, and
accurately reflect in all material respects the documentation and materials prepared and used by Calliditas in its business activities
in the ordinary course.


 


10.3            Additional
Representations and Warranties of Partner. Partner, on behalf of itself and its Affiliates (other
than Excluded Partner Affiliates) hereby further represents and warrants to Calliditas, as of the Effective Date:


 


(a)            there
are no pending, or to the knowledge of Partner, threatened, claims or disputes by any Person against it that would materially impair
(i) Partner’s ability to perform its obligations under this Agreement or (ii) Calliditas right to exploit the licenses
and other rights granted by Partner to Calliditas under this Agreement; and


 






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(b)            Partner
is solvent and has the ability to pay and perform all of its obligations as and when such obligations become due, including payment obligations
and other obligations under this Agreement.


 


10.4            Sanctions.
Each Party herewith covenants that it shall and shall ensure that Persons associated with it or other Persons who are enjoying rights
or performing services or providing Products in connection with this Agreement or the Supply Agreement shall:


 


(a)            comply
with all Applicable Laws, statutes and regulations in accordance with or in relation to this Agreement, including but not limited to
any sanctions control regulations, including but not limited those of the United States of America, the European Union, Germany and the
United Kingdom;


 


(b)           guarantee
that neither it nor its Affiliates or shareholder(s) or managers is a sanctioned person as defined under the applicable sanctions
control regulations mentioned under (a) above;


 


(c)            not
do, or omit to do, any act that will cause or lead the other Party to be in breach of any of the sanctions control regulations mentioned
under (a) above; and


 


(d)            promptly
report to the other Party if it becomes aware that either it or any of its Affiliates, managers or shareholder(s) or other Persons
who are enjoying rights or performing services or providing Products in connection with this Agreement or the Supply Agreement are or
may be in breach of the sanctions control regulations as mentioned under (a) above or become a listed/sanctioned person or organization
on any sanctions list maintained by the United Nations, the European Union or the United States.


 


10.5            Prohibited
Conduct. Each Party covenants to the other that such Party and its Affiliates and its and their
employees and contractors will not make, offer, give, promise to give, or authorize, any bribe, kickback, payment or transfer of anything
of value, directly or indirectly through Third Parties, to any Government Official for the purpose of: (a) improperly influencing
any act or decision of the Person or Government Official; (b) inducing the Person or Government Official to do or omit to do an
act in violation of a lawful or otherwise required duty; (c) securing any improper advantage; or (d) inducing the Person or
Government Official to improperly influence the act or decision of any organization, including any government or government instrumentality,
to assist any Party in obtaining or retaining business. For the purpose of this Article 10.5 “Government Official”
means: (x) any officer, employee (including physicians, hospital administrators, or other healthcare professionals), agent, representative,
department, or agency, of any Governmental Authority; (y) any candidate for political office, any political party or any official
of a political party; or (z) any Person acting in an official capacity on behalf of any of the foregoing.


 






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10.6            Ongoing
Covenant of Calliditas. During the Term, Calliditas shall not enter into any agreement with
a Third Party that conflicts with the rights and licenses granted by Calliditas to Partner under this Agreement.


 


10.7            Disclaimer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 10, EACH PARTY DISCLAIMS ANY AND ALL
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, AND NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR
WARRANTY THAT THE RESEARCH, DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF ANY PRODUCT PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL.


 


Article 11


 


INDEMNIFICATION AND LIMITATION OF LIABILITY


 


11.1            Indemnification
by Partner. Subject to Article 11.3, Partner shall indemnify, defend and hold Calliditas,
its Affiliates, and their respective directors, officers and employees (collectively, the “Calliditas Indemnitees”)
harmless from and against any and all costs, fees, expenses, losses, liabilities, and damages, including reasonable legal expenses and
attorneys’ fees (collectively, “Losses”) suffered or incurred by any Calliditas Indemnitee as a result of any
claim, demand, action or other proceeding (“Claims”) brought by a Third Party against a Calliditas Indemnitee, in
each case to the extent to the extent such Claim and Losses arise out of: [***].


 


11.2            Indemnification
by Calliditas. Subject to Article 11.3, Calliditas shall indemnify, defend and hold Partner,
its Affiliates, and their respective directors, officers and employees (collectively, the “Partner Indemnitees”) harmless
from and against any and all Losses suffered or incurred by any Partner Indemnitee as a result of any Claim brought by a Third Party
against a Partner Indemnitee, in each case to the extent to the extent such Claim and Losses arise out of: [***].


 


11.3            Indemnification
Procedures. A Party seeking indemnification under Article 11.1 or 11.2 hereof for its applicable
Calliditas Indemnitees or Partner Indemnitees (the “Indemnitee”) shall promptly notify the other Party (the “Indemnitor”)
in writing of the Claim. The Indemnitee shall permit, and shall cause its Affiliates and their respective directors, officers, employees
and agents to permit, the Indemnitor to have complete control of the defense or settlement of such Claim (except as set forth below)
so long as it promptly assumes the defense and prosecutes the defense or settlement with appropriate diligence and care. The Indemnitor
shall have the authority, at its discretion, to settle any such Claim only with the prior written consent of the Indemnitee; provided,
however, that such consent shall not be unreasonably withheld or delayed so long as such settlement does not adversely affect
the Indemnitee’s rights hereunder (including, as concerns Calliditas, its activities in the Calliditas Territory), or impose any
obligations (whether as payment or otherwise) on the Indemnitee in addition to those set forth herein. At the cost of the Indemnitor,
the Indemnitee and its directors, officers, employees and agents shall cooperate fully with the Indemnitor and its respective legal representatives
in the investigation and defense of any Claim covered by this indemnification. The Indemnitor shall keep the Indemnitee reasonably informed
of the progress of the action and shall consider the comments and observations of the Indemnitee timely given in the course of the proceedings.
The Indemnitee shall have the right, but not the obligation, to be represented by counsel of its own selection and at its expense. Notwithstanding
the foregoing, the Indemnitee may be represented by separate counsel at the expense of the Indemnitor if a conflict of interest exists
between the interests of the Indemnitor and Indemnitee so that a single counsel representing Indemnitor cannot adequately defend the
rights of the Indemnitee.


 






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11.4            Insurance.
Each Party shall maintain insurance with a creditworthy insurance company against [***].


 


11.5            Limitation
of Liability. EXCEPT IN THE CASE OF (A) A PARTY’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT,
OR (B) DEATH OR PERSONAL INJURY CAUSED BY A PARTY`S NEGLIGENCE, OR (C) A BREACH OF THE OBLIGATIONS OF A PARTY UNDER ARTICLE 8, IN
NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES,
HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING
UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF THIS AGREEMENT. THE FOREGOING LIMITATION WILL NOT LIMIT EITHER PARTY’S
INDEMNIFICATION OBLIGATIONS TO THE OTHER PARTY UNDER ARTICLE 11 IN RESPECT OF ANY
THIRD-PARTY CLAIM.


 


11.6            Duty
to Mitigate. Each Party shall take, in relation to any fact, matter, event or circumstance which
might give rise to a claim against the other Party all such reasonable steps and action as are necessary to avoid or mitigate the liability
(or potential losses or damages) of such other Party in relation to such claim.


 


Article 12


 


TERM AND TERMINATION


 


12.1            Term.
This Agreement shall be effective as of the Effective Date and, unless terminated earlier, this Agreement shall continue on a country-by-country
basis until the date on which the Royalty Term has expired in such country and shall finally expire upon the expiration of the last-to-expire
Royalty Term (the “Term”).


 


12.2            Termination.


 


(a)            Mutual
Agreement. This Agreement may be terminated in its entirety at any time upon mutual written agreement between the Parties.


 


(b)           Termination
by Partner for Convenience or by Calliditas for Cessation of Activities.


 






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(i)            This
Agreement may be terminated at any time by Partner upon eighteen (18) months’ prior written notice to Calliditas.


 


(ii)           This
Agreement may be terminated by Calliditas upon written notice to Partner in the event that, [***].


 


(c)            Termination
by Partner or Renegotiation for Material Event. This Agreement may be terminated by Partner upon written notice to Calliditas with
immediate effect (subject to Article 12.2(g)), if:


 


(i)            [***];
or


 


(ii)           [***];
or


 


(iii)          [***],
or


 


(iv)          [***].


 


In the event that the Orphan Designation
is revoked or otherwise terminates prematurely, the Parties will renegotiate in good faith and in reasonable time before the actual expiry
of the Orphan Designation whether and how this Agreement shall continue, in particular with regard to the territorial exclusivity (Article 5.7)
of this Agreement.


 


(d)            Challenge.
Calliditas may terminate this Agreement at any time upon written notice to Partner in the event that Partner or any of its Affiliates
directly or indirectly challenges in a legal or administrative proceeding the patentability, enforceability or validity of any patent
or patent application within any of the Licensed Patents (a “Patent Challenge”).


 


(e)            Material
Breach. Subject to Article 12.2(f), either Party may terminate this Agreement at any time upon written notice to the other Party
if the other Party is in material breach of this Agreement and such material breach, if curable, is not cured within [***], so long as
the breaching party is making a good faith effort to cure such breach. Termination shall not be the sole remedy for material breach of
this Agreement, and a Party may choose to continue to perform hereunder and in response to any material breach may bring a claim for
damages and other available remedies, and bringing such a claim shall not constitute a breach of this Agreement.


 


(f)            Failure
to Use Commercially Reasonable Efforts. [***].


 


(g)           Dispute.
Within [***] Business Days after receipt of:


 


(i)            a
notice of termination issued pursuant to Article 12.2(b)(ii), 12.2(c) or 12.2(e), but excluding in connection with alleged
breach by Partner of its diligence obligation to use Commercially Reasonable Efforts to Commercialize the Product (which is the subject
of Article 12.2(f)); or


 






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(ii)            a
notice of continuation issued pursuant to Article 12.4;


 


if the recipient
of such notice disputes in good faith the validity of such notice [***].


 


(h)           Insolvency.
Either Party may terminate this Agreement upon written notice to the other Party, if the other Party suffers an Insolvency Event.


 


(i)            No
Rescission Rights. Except as otherwise expressly provided for in this Agreement, the right of the Parties to terminate this Agreement
or any right or remedy which would have a similar effect in connection with any breach of this Agreement (such as a claim for rescission
of this Agreement) shall be excluded, and each Party waives any such right.


 


12.3            Consequences
of Termination in Selected Termination Scenarios. Upon termination of this Agreement pursuant
to Article 12.2 the following shall apply:


 


(a)            Termination
of Licenses. All licenses granted by Calliditas under this Agreement shall terminate.


 


(b)            New
Partner IP License. [***].


 


(c)            Sell
Off of Product. Partner shall have the right to sell off, for a period of up to [***] after the effective date of termination, all
Product then in Partner’s or its Affiliates’ inventory, or on order from Calliditas (subject to the Supply Agreement), on
the date on which the applicable notice of termination is provided; provided that Partner pays to Calliditas any payments due
in accordance with this Agreement in connection with such sales.


 


(d)            Transfer
of Clinical Trials. [***].


 


(e)            Regulatory
Submissions. [***].


 


[***].


 


(f)            Copies
of Data. To the extent not already provided to Calliditas, Partner as promptly as reasonably practicable shall provide Calliditas
with copies of all New Partner IP regarding the Product and the Partner Territory, and data collected or generated with respect to the
Product in Partner’s possession or Control.


 


(g)            Return
of Confidential Information. Each Party will promptly return to the other Party (or as directed by such other Party destroy and certify
to the other Party in writing as to such destruction) all of such other Party’s Confidential Information that is in the possession
or control of such Party (or any of its Affiliates, licensees or contractors), except that such Party will have the right to retain one
(1) copy of intangible Confidential Information of such other Party for legal purposes and will not be required to return or destroy
back-up copies of electronic files provided that they are not accessed.


 






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(h)            Trademarks.
[***].


 


(i)            Compensation
Payments. [***].


 


12.4            Partner
Option to Continue Agreement. [***].


 


[***].


 


12.5            Further
Effects of Expiration or Termination; Survival.


 


(a)            Termination
of Rights and Obligations. Except as set forth in this Article ‎12.5, all rights and obligations of the Parties under this
Agreement will terminate as of the effective date of such termination.


 


(b)            Expiry.


 


(i)            Upon
expiry of this Agreement pursuant to Article 12.1 (not early termination) for the Product in a particular country of the Partner
Territory all licenses granted by Calliditas to Partner under this Agreement shall convert into irrevocable, perpetual, royalty free
and fully paid-up licenses with respect to such Product in such country. Nothing in this Article 12.5(b) shall limit the consequences
of early termination of this Agreement as set forth in Article 12.3.


 


(ii)           Upon
expiry of this Agreement pursuant to Article 12.1 (not early termination) in respect of all countries of the Partner Territory,
subject to only the surviving terms and conditions of this Agreement, Calliditas, on behalf of itself and its Affiliates, hereby grants
to Partner and its Affiliates (only for as long as they remain Affiliates of Partner and excluding Excluded Partner Affiliates) the rights
in respect of Manufacture set out in Article 3.1(d), which rights shall be irrevocable, perpetual, royalty free and fully paid-up.


 


(c)            Accrued
Obligations; Remedies. Expiration or termination of this Agreement for any reason shall not relieve either Party of any obligation
which has accrued prior to the effective date of such termination or expiration, which obligations shall remain in full force and effect
for the period provided therein. Except as otherwise expressly set forth herein, termination of this Agreement in accordance with and
fulfillment of all obligations set forth in this Article 12 shall not affect any other rights or remedies that may be available
to a Party in law or equity, all remedies being cumulative and not exclusive. For the avoidance of doubt, termination of this Agreement
will not affect any Pharmacovigilance Agreement, which will continue to survive so long as any Products thereunder are being Commercialized.


 






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(d)           Survival.
In addition to the termination consequences set forth in Article 12.3 (and any Articles referenced therein), the following provisions
will survive expiration or termination of this Agreement for any reason: Article 1 (Definitions), Article 2.11(a), Articles 6.6
to 6.11, Article 8 (Confidentiality and Data Protection), Article 9 (Public Announcements and Use of Names), Article 11
(Indemnification and Limitation of Liability), Article 13 (Miscellaneous), Articles 7.1 to 7.3, Articles 12.3 and 12.5
and any other obligations and rights which are intended to survive this Agreement (whether expressly or due to their context and content).


 


Article 13


 


MISCELLANEOUS


 


13.1            Notices.
Any notice, request, demand, waiver, consent, approval or other communication which is required or permitted to be given to any Party
shall be in writing, in English, and shall be deemed given only when delivered to the Party either (i) personally or (ii) by
courier, in each case to the address set out below or at such other address as such Party may from time to time specify by notice given
in the manner provided herein to the Party entitled to receive notice hereunder. If transmitted via electronic mail, a hard copy shall
be delivered personally or by registered mail in accordance with this clause.


 


For Calliditas:


 


Calliditas Therapeutics AB, at the addresses first noted
above, and with a copy to [***].


 


For Partner:


 


STADA Arzneimittel AG, at the addresses first noted above,
and with a copy to


 


Executive Vice President Europe (Steffen Wagner), [***], and


 


Executive Vice President Legal (Dr. Christoph Dengler),


 


[***].


 


13.2            Entire
Agreement. This Agreement, the Supply Agreement, the Quality Agreement and the Pharmacovigilance
Agreement (including any Schedules or other attachments hereto or thereto and the agreements entered into hereunder and thereunder, as
applicable) constitutes the entire agreement between the Parties with respect to the subject matter hereof. This Agreement supersedes
any prior or contemporaneous agreements and understandings, whether written or oral, between the Parties with respect to the subject
matter hereof. All information disclosed by a Party during diligence regarding negotiation of this Agreement and the transactions related
to this Agreement shall be deemed such Party’s Confidential Information for the purposes of this Agreement. In case of conflicting
provisions, the Quality Agreement shall prevail with respect to all matters relating to the quality assurance of the Products, the Supply
Agreement (including the Product Schedule (as such term is defined under the Supply Agreement)) shall prevail with respect to all matters
concerning the order, purchase, Manufacture and supply, storage, and shipping of Products by Calliditas to Partner, the Pharmacovigilance
Agreement shall prevail with respect to all matters concerning the receipt, investigation, and reporting of complaints, adverse events,
recalls, and any other information related to the safety of a Product and this Agreement shall prevail with respect to all other matters.


 






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13.3            Assignment.
Neither Party may assign or otherwise transfer its rights or obligations under this Agreement without the prior written consent of the
other Party, such consent not to be unreasonably withheld or delayed, except that:


 


(a)            Partner
hereby gives consent to Calliditas’ entitlement to assign, without Partner’s further prior written consent, this Agreement
and its rights and obligations hereunder in whole or in part to (i) an Affiliate, or (ii) a Third Party that acquires, by or
otherwise in connection with, a merger, sale of assets or stock, reorganization, consolidation or otherwise, all or substantially all
of the Licensed Intellectual Property.


 


(b)            Calliditas
hereby gives consent to Partner’s entitlement to assign, without Calliditas’ further prior written consent, this Agreement
and its rights and obligations hereunder as a whole (but not in part) to (i) an Affiliate (only for so long as such entity remains
an Affiliate of Partner and excluding Excluded Partner Affiliates); or (ii) a Third Party that acquires, by or otherwise in connection
with, a merger, sale of assets or stock, reorganization, consolidation or otherwise, all or substantially all of the business, assets,
personnel, contracts and resources of the business unit primarily involved in implementation of Partner’s performance obligations
under this Agreement (provided that such business unit is also the business unit primarily involved in the commercialization of other
products, and all rights and obligations with respect to such other products are also being acquired by such Third Party).


 


Any assignment of the rights
or obligations under this Agreement in violation of this Article 13.2 shall be null and void. This Agreement shall be binding upon
and inure to the benefit of the Parties and their respective successors and permitted assigns.


 


13.4            Force
Majeure. Both Parties shall be excused from the performance of their obligations under this
Agreement to the extent that such performance is prevented or delayed by Force Majeure and the nonperforming Party promptly provides
notice of the prevention or delay to the other Party. Such excuse shall be continued so long as the condition constituting Force Majeure
continues and the nonperforming Party takes reasonable efforts to minimize the effect of and overcome or remove the cause or condition
causing such Force Majeure. For purposes of this Agreement, “Force Majeure” shall mean an act of God, war, civil commotion,
terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production
facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided, that such
failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected
from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). Notwithstanding
the foregoing, a Party shall not be excused from making payments owed hereunder because of a Force Majeure affecting such Party.


 






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13.5            Headings.
The descriptive headings contained in this Agreement are for convenience of reference only and shall not affect in any way the meaning
or interpretation of the Agreement.


 


13.6            Independent
Contractor. Each Party shall be acting as an independent contractor in performing under
this Agreement and shall not be considered or deemed to be an agent, employee, joint venturer or partner of the other Party.


 


13.7            Severability.
If any term or other provision of this Agreement is invalid, illegal or incapable of being enforced by any law or public policy,
all other terms and provisions of this Agreement shall nevertheless remain in full force and effect so long as the economic or legal
substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party.


 


13.8            No
Third-Party Beneficiaries. Except as provided in Article 11 in respect to Calliditas
Indemnitees and Partner Indemnitees, nothing in this Agreement, either express or implied, is intended to or shall confer upon any Third
Party any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.


 


13.9            Amendment.
This Agreement may not be amended or modified except by an instrument in writing signed by authorized representatives of Partner
and Calliditas.


 


13.10          Governing
Law. This Agreement will be governed by and interpreted under the laws of England and
Wales. Any dispute, controversy, claim or difference of any kind whatsoever arising out of or in connection with this Agreement will
be resolved exclusively in accordance with Article 13.10 provided, however, that all questions concerning the construction or effect
of Patents will be determined in accordance with the laws of the country or other jurisdiction in which the particular patent within
such Patents has been filed or granted, as the case may be. Any communication or proceedings resulting from disputes under this Agreement
will be in English language. The Parties agree to exclude the application to this Agreement of the United Nations Conventions on Contracts
for the International Sale of Goods (1980).


 


13.11          Dispute
Resolution; Jurisdiction.


 


(a)            Disputes.
Except as otherwise expressly set forth in this Agreement, in the event of any dispute under, relating to or in connection with this
Agreement or its existence, construction, negotiation, performance, termination or validity, (a “Dispute”), the Parties
shall refer such Dispute to the Applicable Senior Officers for attempted resolution by good faith negotiations within [***] after such
referral is made. If the Applicable Senior Officers are unable to resolve the Dispute within the time allotted, either Party may proceed
as set forth below in Article 13.11(b).


 


(b)            Jurisdiction.
Subject to Article 13.11(a), any Dispute shall be referred to and finally resolved by arbitration under the Rules of Arbitration
of the International Chamber of Commerce by one (1) or more arbitrators appointed in accordance with the said Rules. The seat, or
legal place, of arbitration shall be London, United Kingdom. The language to be used in the arbitral proceedings shall be English.


 






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(c)            Conservatory,
Emergency, or Interim Relief. Nothing in this Article 13.11 shall prevent a Party from seeking conservatory, emergency, or interim
relief not available from such arbitrators in any court of competent jurisdiction.


 


13.12          No
Waiver. The failure of either Party to enforce at any time for any period the provisions
of or any rights deriving from this Agreement shall not be construed to be a waiver of such provisions or rights or the right of such
Party thereafter to enforce such provisions.


 


13.13          Interpretation.
Whenever any provision of this Agreement uses the term “including” (or “includes”), such term will be deemed
to mean “including without limitation” (or “includes without limitation”). The word “or” is used
in the inclusive sense (and/or). “Herein,” “hereby,” “hereunder,” “hereof” and other
equivalent words refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such
word is used. All definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or
the plural. Unless otherwise provided, all references to Articles and Exhibits in this Agreement are to Articles and Exhibits of this
Agreement. References to any Articles include Articles and subsections that are part of the related Article (e.g., an Article numbered
 “Article 2.1” would be part of “Article 2”, and references to “Article 2” would also
refer to material contained in the subsection described as “Article 2.1”).


 


13.14          Counterparts.
This Agreement may be executed in one or more counterparts, and by the respective Parties in separate counterparts, each of which
when executed shall be deemed to be an original but all of which taken together shall constitute one and the same Agreement.


 


[SIGNATURES FOLLOW ON NEXT PAGE]


 






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IN WITNESS WHEREOF, the Parties
hereto have caused this Agreement to be executed as of the date first written above by their respective duly authorized officers.


 


	 	Calliditas Therapeutics AB
	 	 
	 	 	 
		By:	
	 		Name:  Renee Aguiar-Lucander
	 		Title:    CEO
	 	 	 
	 	 	 
	 	STADA Arzneimittel AG
	 	 
	 	 	 
	 	By:	 
	 		 Name:  [***]
	 		Title:    CEO
	 	 	 
	 	By:	 
	 		Name:  [***]
	 		Title:    EVP Global Legal / General Counsel



 






    58


     


    

 


Schedule 1


 


Calliditas Trademarks


 


[***]


 






    59


     


    

 


Schedule 2


 


Formula for Calculation of Net Sales in Case of
Combination or Combined Dosage Therapy Products


 


[***]


 









    60


     


    

 


Schedule 3


 


Licensed Patents


 


[***]


 






    61


     


    

 


Schedule 4


 


Press Releases


 


 


 


	Stockholm, Sweden	   July 21, 2021




 




Calliditas Therapeutics and STADA partner to register and commercialize specialty therapy for IgA Nephropathy in Europe


		·	Calliditas and
                                            STADA partner to bring a specialty therapy focused on downregulating IgA1 to European patients.
                                            If approved, it would be the first-ever approved treatment in the EU for chronic autoimmune
                                            kidney disease IgA Nephropathy (IgAN)






		·	Partnership for
                                            this oral orphan-drug candidate combines Calliditas’ drug-delivery expertise with STADA’s
                                            pan-European marketing and sales expertise, including for specialty and nephrology medicines






		·	Deal covering European
                                            Economic Area (EEA) member states, Switzerland and the UK is valued at a total of 97.5 million
                                            EUR ($115m), plus royalties



 


Stockholm, Sweden; Bad Vilbel, Germany. 21 July 2021 –
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) and STADA Arzneimittel AG (“STADA”)
announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the
treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states,
Switzerland and the UK.


 


Under the terms of the agreement, Calliditas is entitled receive an
initial upfront payment of 20M EUR ($24m) upon signing and up to an additional 77.5M EUR ($91m) in future payments linked to pre-defined
regulatory and commercialization milestones. STADA is also obligated pay tiered royalties on net sales expressed as a percentage between
the low twenties and the low thirties.


 


The partnership relates to a novel oral formulation, developed under
the project name ‘Nefecon’, of a potent and well-known active substance – budesonide – designed to target down
regulation of IgA1 with a view to be disease modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug
designation in 2016, would be the first treatment authorized in the European Union for IgAN, a rare autoimmune disease. IgAN, also known
as Berger ́s disease, is a serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end
stage renal disease and thus requiring dialysis or a kidney transplant. Prevalence in Europe is estimated at 4 in 10,000, translating
into approximately 200,000 patients.


 


“We are excited to be entering into this partnership with STADA
to bring this IgAN therapy to market in Europe, where there is a significant unmet medical need for this patient population. We look
forward to working in close collaboration with STADA to pursue marketing authorization with the goal of bringing the first ever EU-approved
medication in IgAN to patients as soon as possible, utilizing STADA’s extensive marketing and sales platform throughout Europe,”
said Renée Aguiar-Lucander, CEO of Calliditas.


 


“This partnership, which leverages Calliditas’ drug-delivery
expertise and clinical data in this under-served patient population, further validates STADA’s position as a go-to-partner for
specialty pharmaceuticals, as well as for generics and consumer health products,” commented STADA CEO Peter Goldschmidt. “This
value-added novel formulation for a large orphan indication will complement STADA’s offerings in nephrology, where we have built
strong expertise over more than a decade through our epoetin zeta biosimilar and where we continue to place a clear strategic focus on
seeking further opportunities to bring new options to patients.”


 






    62


     


    

 


The novel formulation is designed to deliver the drug to the Peyer’s
patch region of the lower small intestine, where the disease originates as per the predominant pathogenesis models. The formulation uses
a unique two-step technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to
be released in a pulse like fashion only when it reaches the ileum in the lower small intestine. In addition to its potent local effect,
another advantage of using this active substance is that it has very low bioavailability, with around 90% being inactivated in the liver
before it reaches the systemic circulation. This means that a high concentration can be applied locally where needed, whilst limiting
systemic exposure.


 


On May 28, 2021, Calliditas announced that the company had, under
the drug-development candidate name Nefecon, submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA)
for a novel oral formulation of budesonide targeting down regulation of IgA1 for the treatment of primary IgAN. The company also filed
an application for accelerated approval in the US on March 15, 2021 and was granted priority review in April 2021. The commercial
brand name for this therapy in Europe will be determined and disclosed at a later date.


 


Calliditas ́ oral formulation has been granted Accelerated Assessment
procedure by the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency, which is intended to expedite access
to drugs that the CHMP considers to be of major therapeutic interest from the point of view of public health and in particular from the
viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum timeframe for review of the MAA to 150 days (excluding
clock-stops).


 


IgAN is designated as an orphan disease in both the US and Europe.
In Europe, an orphan disease is defined as a disease or condition affecting no more than five in 10,000 European citizens with no satisfactory
method of diagnosis, prevention or treatment. Orphan incentives consist of ten years of market exclusivity from the grant date of marketing
approval in the EU, protocol assistance and scientific advice, fee reductions on EMA procedural activities and eligibility for EU grants.


 


If approved, the product could be available to patients in Europe
in the first half of 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which
has the potential to be disease modifying.


 


Torreya acted as exclusive financial advisor to Calliditas on the
transaction.


 


For further information, please contact:


 


Marie Galay, IR Manager, Calliditas


Tel.: +44 79 55 12 98 45, email: marie.galay@calliditas.com


 


STADA Arzneimittel AG


Stadastrasse 2–18


61118 Bad Vilbel - Germany


Phone: +49 (0) 6101 603-165


Fax: +49 (0) 6101 603-215


For Media Relations, email: press@stada.de


Or visit us on the Internet at www.stada.com/press


For Investor & Creditor Relations, email: ir@stada.de


Or visit us on the Internet at www.stada.com/investor-relations


 


The information in the press release is information that Calliditas
is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of
the Calliditas contact person set out above, on July 21, 2021 at 8:30 a.m. CET.


 






    63


     


    

 


About STADA Arzneimittel AG


 


STADA Arzneimittel AG is headquartered in Bad
Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics, specialty pharma and non-prescription consumer
healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries. In financial year 2020, STADA
achieved group sales of EUR 3,010.3 million and adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) of EUR
713.3 million. As of December 31, 2020, STADA employed 12,301 people worldwide.


 


About Calliditas


 


Calliditas Therapeutics is a biopharma company based in Stockholm,
Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal
and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel
oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of adults with the autoimmune
renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical need and there are no approved treatments. Calliditas
has recently read out topline data from Part A of its global Phase 3 study in IgAN and, if approved, aims to commercialize Nefecon
in the United States. Calliditas is also planning to start clinical trials with NOX inhibitors in primary biliary cholangitis and head
and neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com
for further information.


 


Forward-Looking Statements


 


This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding Calliditas’
strategy, business plans, regulatory submissions and focus, as well as Calliditas’s partnership with STADA, the parties’
plans with respect to registration and commercialization of the specialty therapy, the terms of the collaboration and the intended benefits
therefrom, the regulatory pathway and interactions for Nefecon, including timing of review and assessment of the candidate, and the intended
benefits of regulatory designations such as Accelerated Assessment and orphan disease. The words “may,” “will,”
 “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,”
 “believe,” “estimate,” “predict,” “project,” “potential,” “continue,”
 “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements
contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations
and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ
materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation,
any related to Calliditas’ business, operations, the conduct of Calliditas’s partnership with STADA, the potential for regulatory
acceptance for and the success and timeline of its regulatory marketing application for Nefecon, clinical trials, supply chain, strategy,
goals and anticipated timelines, competition from other biopharmaceutical companies, and other risks identified in the section entitled
 “Risk Factors” in Calliditas’ reports filed with the Securities and Exchange Commission. Calliditas cautions you not
to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Calliditas disclaims any obligation
to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which
any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking
statements. Any forward-looking statements contained in this press release represent Calliditas’ views only as of the date hereof
and should not be relied upon as representing its views as of any subsequent date.


 






    64


     


    

 


 


 


Calliditas Therapeutics and STADA partner to register and commercialize
specialty therapy for IgA Nephropathy in Europe


 


		·	Calliditas and STADA
                                            partner to bring a specialty therapy focused on downregulating IgA1 to European patients.
                                            If approved, it would be the first-ever approved treatment in the EU for chronic autoimmune
                                            kidney disease IgA Nephropathy (IgAN)



 


		·	Partnership for this
                                            oral orphan-drug candidate combines Calliditas’ drug-delivery expertise with STADA’s
                                            go-to-partner strategy and pan-European marketing and sales expertise, including for specialty
                                            and nephrology medicines



 


		·	Deal covering European
                                            Economic Area (EEA) member states, Switzerland and the UK is valued at a total of EUR 97.5
                                            million ($115m), plus royalties



 


Stockholm, Sweden; Bad Vilbel, Germany, 21 July 2021 –
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) and STADA Arzneimittel AG (“STADA”)
announced today that they have entered into a license agreement to register and commercialize a novel specialty drug candidate for the
treatment of the chronic autoimmune kidney disease Immunoglobulin A Nephropathy (IgAN) in the European Economic Area (EEA) member states,
Switzerland and the UK.


 


The partnership relates to a novel oral formulation,
developed under the projectname Nefecon, of a potent and well-known active substance – budesonide – designed to target down
regulation of IgA1 with a view to be disease-modifying. If approved, this value-added specialty medicine, which received an EU orphan-drug
designation in 2016, would be the first treatment authorised in the European Union for IgAN, a rare autoimmune disease. IgAN, also known
as Berger’s disease, is a serious progressive autoimmune disease in which up to 50% of patients end up at risk of developing end-stage
renal disease and thus requiring dialysis or a kidney transplant.1
Prevalence in Europe is estimated at 4 in 10,000, translating into approximately 200,000 patients.


 


“This partnership, which leverages Calliditas’ drug-delivery
expertise and clinical data in this under-served patient population, further validates STADA’s position as a go-to-partner for
specialty pharmaceuticals, as well as for generics and consumer health products,” commented STADA CEO Peter Goldschmidt. “This
value-added novel formulation for a large orphan indication will complement STADA’s offerings in nephrology, where we have built
strong expertise over more than a decade through our epoetin zeta biosimilar and where we continue to place a clear strategic focus on
seeking further opportunities to bring new options to patients.”


 





 






1
EU/3/16/1778 | European Medicines Agency (europa.eu)


 






    65


     


    

 


“We are excited to be entering into this partnership with STADA
to bring this IgAN therapy to market in Europe, where there is a significant unmet medical need for this patient population. We look
forward to working in close collaboration with STADA to pursue marketing authorisation with the goal of bringing the first ever EU-approved
medication in IgAN to patients as soon as possible, utilizing STADA’s extensive marketing and sales platform throughout Europe,”
said Renée Aguiar-Lucander, CEO of Calliditas.


 


The novel formulation is designed to deliver the drug to the Peyer’s
patch region of the lower small intestine, where the disease originates as per the predominant pathogenesis models. The formulation uses
a unique two-step technology, which allows for the substance to pass through the stomach and intestine without being absorbed, and to
be released in a pulse-like fashion only when it reaches the ilium in the lower small intestine.


 


In addition to its potent local effect, another advantage of using
this active substance is that it has very low bioavailability, with around 90% being inactivated in the liver before it reaches the systemic
circulation. This means that a high concentration can be applied locally where needed, whilst limiting systemic exposure.


 


On 28 May 2021, Calliditas announced that the company had, under
the drug-development candidate name Nefecon, submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA)
for a novel oral formulation of budesonide targeting down regulation of IgA1 for the treatment of primary IgAN. The company also filed
an application for accelerated approval in the US on March 15, 2021 and was granted priority review in April 2021. The commercial
brand name for this therapy in Europe will be determined and disclosed at a later date.


 


Calliditas’ oral
formulation has been granted Accelerated Assessment procedure by the Committee for Human Medicinal Products (CHMP) within the European
Medicines Agency, which is intended to expedite access to drugs that the CHMP considers to be of major therapeutic interest from the
point of view of public health and in particular from the viewpoint of therapeutic innovation. Accelerated assessment reduces the maximum
timeframe for review of the MAA to 150 days (excluding clock-stops)2.


 






    66


     


    

 


IgAN is designated as an orphan disease in
both the US and Europe. In Europe, an orphan disease is defined as a disease or condition affecting no more than five in 10,000
European citizens with no satisfactory method of diagnosis, prevention or treatment3. Orphan incentives consist of 10 years of market exclusivity from the grant date of marketing approval in the EU,
protocol assistance and scientific advice, fee reductions on EMA procedural activities and eligibility for EU grants.


 


If approved, the product could be available to patients in Europe
in the first half of 2022 and would become the first therapy specifically designed and approved for the treatment of IgAN, and which
has the potential to be disease-modifying.


 


Under the terms of the agreement, Calliditas is entitled receive an
initial upfront payment of EUR 20m ($24m) upon signing and up to an additional EUR 77.5m ($91m) in future payments linked to pre-defined
regulatory and commercialization milestones.


 


About STADA Arzneimittel AG

STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of generics,
specialty pharma and non-prescription consumer healthcare products. Worldwide, STADA Arzneimittel AG sells its products in approximately
120 countries. In financial year 2020, STADA achieved group sales of EUR 3,010.3 million and adjusted earnings before interest, taxes,
depreciation and amortization (EBITDA) of EUR 713.3 million. As of 31 December 2020, STADA employed 12,301 people worldwide.


 


About Calliditas Therapeutics

Calliditas Therapeutics is a biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing
novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’
lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant,
for the treatment of adults with the autoimmune renal disease primary IgA nephropathy (IgAN), for which there is a high unmet medical
need and there are no approved treatments. Calliditas has recently read out topline data from Part A of its global Phase 3 study
in IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is also planning to start clinical trials with
NOX inhibitors in primary biliary cholangitis and head and neck cancer. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and
the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.


 





 






2
Accelerated assessment | European Medicines Agency (europa.eu)


3
Orphan designation: Overview | European Medicines Agency (europa.eu)



 






    67


     


    

 


STADA information for journalists:


 


STADA Arzneimittel AG - Media Relations


Stadastrasse 2-18, 61118 Bad Vilbel - Germany


Phone: +49 (0) 6101 603-165


Fax: +49 (0) 6101 603-215


E-Mail: press@stada.de


Or visit us on the Internet at www.stada.com/press


 


STADA information for capital market participants:


STADA Arzneimittel AG - Investor & Creditor Relations


Stadastrasse 2-18, 61118 Bad Vilbel – Germany


Phone: +49 (0) 6101 603-4689


Fax: +49 (0) 6101 603-215


E-mail: ir@stada.de


Or visit us on the Internet at www.stada.com/investor-relations


 




Calliditas information for journalists and investors:


Marie Galay, IR Manager, Calliditas

Tel.: +44 79 55 12 98 45

E-mail: marie.galay@calliditas.com


 






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Schedule 5


 


Exceptions to Representation and Warranties of
Calliditas


 


[***]


 






    69


     


    

 


Schedule 6


 


Commitments to the Regulatory Authorities


 


[***]


 






    70


     


    

 


Schedule 7


 


Expert Determination Procedure


 


[***]


 






    71