Exhibit 10.36


 


CERTAIN
IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT 
 IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE
HARM TO THE REGISTRANT IF
 PUBLICLY DISCLOSED. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.


 


PROMOTION AGREEMENT


 


by and between


 


SANDOZ INC.


 


and


 


RAREGEN, LLC


 


August 1, 2018


 






     


     


    

 


TABLE OF CONTENTS


 


Page


 


	ARTICLE 1   DEFINITIONS	1
	ARTICLE 2   RIGHTS AND OBLIGATIONS	10
	2.1   Engagement; Grant of Rights	10
	2.2   Retention of Rights	10
	2.3   Right of Notice	11
	2.4   Non-Competition; Non-Solicitation	11
	2.5   Sandoz Trademarks and Copyrights	12
	2.6   Subcontracting	12
	2.7   Obligation to Manufacture and Supply	13
	2.8   Facility Maintenance; Product Quality Matters	14
	ARTICLE 3   GOVERNANCE	14
	3.1   Formation of the JSC	14
	3.2   Meetings and Minutes	15
	3.3   Procedural Rules	15
	3.4   Specific Responsibilities of the JSC	15
	3.5   JSC Dispute Resolution	16
	ARTICLE 4   RAREGEN ACTIVITIES FOR PRODUCT	17
	4.1   RareGen Activities	17
	4.2   Detailing	17
	4.3   Patient HUB	18
	4.4   Prohibition on Other RareGen Activities; Final Decision Making Authority	19
	4.5   Compliance with Applicable Law; Requirements	19
	4.6   Field Force Personnel Training; Product Materials	20
	4.7   Provisions Related to Field Force Personnel	23
	4.8   Records	25
	4.9   Responsibility for RareGen Activity Costs and Expenses	25
	4.10   Managed Care Activities	25



 






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	ARTICLE 5   REGULATORY, SAFETY AND SURVEILLANCE, COMMERCIAL MATTERS	25
	5.1   Responsibility	25
	5.2   Reporting	26
	5.3   RareGen Involvement	26
	5.4   Pharmacovigilance	27
	5.5   Unsolicited Requests for Medical Information	27
	5.6   Recalls and Market Withdrawals	27
	5.7   Reporting Responsibilities	27
	5.8   Booking of Sales Revenues	28
	5.9   Returns	28
	ARTICLE 6   FINANCIAL PROVISIONS	28
	6.1   Initial Milestone Payment	28
	6.2   Quality Release Milestone Payment	28
	6.3   Profit Sharing	28
	6.4   Acceleration Payment	29
	6.5   Accounting Standards	29
	6.6   Reports; Payments; Cumulative Calculation	29
	6.7   Taxes	29
	ARTICLE 7   AUDIT RIGHTS	30
	7.1   RareGen	30
	7.2   Sandoz	31
	ARTICLE 8   INTELLECTUAL PROPERTY	31
	8.1   Ownership of Intellectual Property	31
	8.2   Title to Trademarks and Copyrights	32
	8.3   Protection of Trademarks and Copyrights	32
	8.4   Disclosure of Know-How	32
	ARTICLE 9   CONFIDENTIALITY	33
	9.1   Confidential Information	33
	9.2   Public Announcements	34
	ARTICLE 10   REPRESENTATIONS AND WARRANTIES	34
	10.1   Representations and Warranties of Sandoz	34
	10.2   Representations, Warranties and Covenants of RareGen	36
	10.3   Disclaimer of Warranty	37



 






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	ARTICLE 11   INDEMNIFICATION; LIMITATIONS ON LIABILITY	38
	11.1   Indemnification by Sandoz	38
	11.2   Indemnification by RareGen	38
	11.3   Indemnification Procedures	39
	11.4   Limitation of Liability	39
	11.5   Insurance	39
	ARTICLE 12   TERM AND TERMINATION	40
	12.1   Term	40
	12.2   Early Termination for Cause	40
	12.3   Early Termination	40
	12.4   Termination Due to Change of Control	41
	12.5   Termination Due to Failure to Achieve Minimum Net Profits	42
	12.6   Effects of Termination	42
	12.7   Survival	42
	ARTICLE 13   MISCELLANEOUS	43
	13.1   Use of Affiliates	43
	13.2   Force Majeure	43
	13.3   Assignment; Change of Control	43
	13.4   Severability	44
	13.5   Notices	44
	13.6   Governing Law	44
	13.7   Dispute Resolution	45
	13.8   Waiver of Jury Trial	45
	13.9   Entire Agreement; Amendments	45
	13.10   Headings	45
	13.11   Independent Contractors	45
	13.12   Third Party Beneficiaries	46
	13.13   Waiver	46
	13.14   Cumulative Remedies	46
	13.15   Waiver of Rule of Construction	46
	13.16   Use of Names	46
	13.17   Further Actions and Documents	46
	13.18   Certain Conventions	46
	13.19   Counterparts	46


 






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EXHIBITS


 


	Exhibit 1.19	 	Competitors
	Exhibit 1.51	 	Minimum Order Quantity
	Exhibit 1.53	 	Example Calculations of Net Sales
	Exhibit 1.71	 	Example of RareGen Activities other than Detailing
	Exhibit 2.7.2	 	Annual Maximum Quantity
	Exhibit 4.2.2	 	Initial RareGen Activity Plan and Budget
	Exhibit 10.2.9	 	Sandoz Compliance Program Requirements




 






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PROMOTION AGREEMENT


 


This Promotion Agreement
(this “Agreement”) is entered into as of the 1st day of August, 2018 (the “Effective Date”)
by and between Sandoz Inc., a corporation organized and existing under the laws of Colorado (“Sandoz”) and RareGen,
LLC, a Delaware limited liability company (“RareGen”). Sandoz and RareGen are each referred to individually
as a “Party” and together as the “Parties”.


 


RECITALS


 


WHEREAS, Sandoz
has developed and has rights to market and sell the generic pharmaceutical product treprostinil in the Territory; and


 


WHEREAS, Sandoz
desires to engage RareGen to conduct certain promotional and non-promotional activities, and RareGen desires to conduct such activities,
for the Product in the Territory for the treatment of pulmonary arterial hypertension.


 


NOW, THEREFORE,
in consideration of the following mutual promises and obligations, and for other good and valuable consideration the adequacy and
sufficiency of which are hereby acknowledged, the Parties agree as follows:


 


ARTICLE 1

DEFINITIONS


 


1.1             
“Acceleration Payment” shall mean, with respect to an FTS Event, the amount equal to the difference,
as of the date of such FTS Event, between (x) the aggregate amounts paid by RareGen to Sandoz pursuant to Sections 6.1
and 6.2, and (y) the aggregate Net Profits received by RareGen under this Agreement. For clarity, in no event shall the Acceleration
Payment exceed twenty million dollars ($20,000,000) or be less than zero dollars ($0.00).


 


1.2             
“Act” shall mean the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., as
it may be amended from time to time, and the regulations promulgated thereunder.


 


1.3             
“Active Pharmaceutical Ingredient” or “API” shall mean treprostinil, a synthetic analog
of prostacyclin (PGI2).


 


1.4             
“Adverse Event” shall mean any untoward medical occurrence in a patient or clinical investigation subject
who is administered the Product, but which does not necessarily have a causal relationship with the treatment for which the Product
is used. An “Adverse Event” can include any unfavorable and unintended sign (including an abnormal laboratory finding),
symptom or disease temporally associated with the use of the Product, whether or not related to the Product. A pre-existing condition
that worsened in severity after administration of the Product would be considered an “Adverse Event”.


 


1.5              “Affiliate”
shall mean, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under
common control with such Person. A Person shall be deemed to control another Person if such Person possesses the power to
direct or cause the direction of the management, business and policies of such Person, whether through the ownership of fifty
percent (50%) or more (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a
particular jurisdiction) of the voting securities of such Person, by contract or otherwise.


 






     


     


    

 


1.6             
“Agreement” shall have the meaning set forth in the preamble to this Agreement.


 


1.7             
“ANDA” shall mean Sandoz’s abbreviated new drug application number 203649.


 


1.8             
“Annual Maximum Quantity” shall mean with respect to the Product and with respect to each Calendar Year
during the Term, the maximum aggregate annual volume of the Product that is planned to be supplied by (or on behalf of) Sandoz
during such Calendar Year as set forth in Exhibit 2.7.2. For the first and last Calendar Year of the Term the maximum
aggregate annual volume will be pro-rated to reflect the contractual length of such Calendar Year.


 


1.9             
“Applicable Laws” shall mean all applicable statutes, ordinances, regulations, codes, rules, or orders
of any kind whatsoever of any Governmental Authority in the Territory, including the Act, the Generic Drug Enforcement Act of 1992
(21 U.S.C. § 335a et seq.), the Prescription Drug Marketing Act, the Anti-Kickback Statute (42 U.S.C. § 1320a-7b
et seq.), the Health Insurance Portability and Accountability Act of 1996, the Federal False Claims Act (31 U.S.C. §§ 3729-3733)
(and applicable state false claims acts), the Physician Payments Sunshine Act, the Code, the Department of Health and Human Services
Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers, released April 2003, the Antifraud and
Abuse Amendment to the Social Security Act, the AMA guidelines on gifts to physicians, generally accepted standards of good clinical
practices adopted by current FDA regulations, as well as any state laws and regulations (i) impacting the promotion of pharmaceutical
products, (ii) governing the storage and distribution of pharmaceutical samples, (iii) governing the provision of meals and other
gifts to medical professionals, including pharmacists, or (iv) governing consumer protection and deceptive trade practices, including
any state anti-kickback/fraud and abuse related laws, all as amended from time to time.


 


1.10         
“Calendar Quarter” shall mean each successive period of three (3) calendar months commencing on
January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall 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 shall end on the last day of the Term.


 


1.11         
“Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1
and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on
December 31 of the year in which the Effective Date occurs, and the last Calendar Year of the Term shall commence on January 1
of the year in which the Term ends and end on the last day of the Term.


 


1.12         
“Certificate of Analysis” shall mean a certificate indicating that the applicable Product conforms to
the applicable Specifications, including by reference to test results demonstrating conformance to the applicable Specifications,
signed by the quality assurance qualified person of Sandoz or one of its Affiliates.


 






     2


     


    

 





1.13         
 “cGMP Requirements” shall mean the FDA’s current good manufacturing practice requirements as promulgated
under the Act at 21 C.F.R. Parts 11, 210 and 211, and as further defined by FDA guidance documents, as such may be amended from
time to time.


 


1.14         
“Change of Control” shall mean, with respect to a Party, the occurrence of any of the following: (a) the
sale of all or substantially all of such Party’s assets or business relating to this Agreement; (b) a merger, reorganization
or consolidation involving such Party in which the voting securities of such Party outstanding immediately prior thereto cease
to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization
or consolidation; or (c) a Person, or group of Persons, acting in concert acquire, directly or indirectly, more than fifty
percent (50%) of the voting equity securities or management control of such Party, in one or a series of related transactions.


 


1.15         
“Claims” shall mean all charges, complaints, actions, suits, proceedings, hearings, investigations, claims,
demands, judgments, orders, decrees, stipulations or injunctions, in each case of a Third Party.


 


1.16         
“Code” shall mean the Code on Interactions with Healthcare Professionals promulgated by the Pharmaceutical
Research and Manufacturers of America (PhRMA)/BIO, as it may be amended.


 


1.17         
“COGs” shall mean Sandoz’s direct costs of components (including API) and labor (including salary,
wages and fringe benefits) incurred in acquiring (including any acquisition costs paid to Third Parties for materials or services
acquired), formulating, manufacturing, packaging and labeling the Product, including quality assurance and quality control activities
necessary to release such Product, together with directly allocable manufacturing overheads (but excluding overheads that cannot
be specifically identified to manufacturing such Product, such as corporate, general and administrative overheads) and the costs
of importation and freight. In the event that additional costs of components are reasonably identified by Sandoz, such costs will
be included in the calculation of COGs. Notwithstanding anything to the contrary, COGs shall be determined in accordance with the
terms and conditions of this Agreement, IFRS (as generally and consistently applied) and shall not include inter-company profits
among Sandoz and its Affiliates. The Parties agree to use commercially reasonable efforts to (i) identify opportunities for
cost savings and (ii) take reasonable actions to reduce the COGs where such opportunities are identified.


 


1.18         
“Commercially Reasonable Efforts” shall mean, with respect to the performance of activities under this
Agreement, reasonable, diligent, good-faith efforts, expertise, degree of skill, and resources that are comparable in quality and
scope to those efforts, expertise, degree of skill and resources that are commonly used in the pharmaceutical industry for a pharmaceutical
product, which has the same regulatory requirements or status, is at a comparable stage of development or product life as the Product,
and that has similar market potential as the Product, taking into account efficacy, safety, approved labeling, the competitiveness
of alternative products in the marketplace, the likelihood of regulatory approval given the regulatory structure involved, the
profitability, the availability of components of Product supplied by Third Parties, and other relevant factors, it being anticipated
that the level of effort may change over time, reflecting changes in the status of the aforementioned attributes and potential
of the Product.


 






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1.19         
 “Competitor” shall mean (a) the entities set forth on Exhibit 1.19 and any of their
respective Affiliates; (b) any Person that derives a material amount of its revenues from one (1) or more health care
products intended for human use or consumption that are directly competitive with the Product; and (c) any Person that controls
Know-How or other intellectual property rights in or with respect to any product in the Field.


 


1.20         
“Confidential Disclosure Agreement” shall have the meaning set forth in Section 9.1.1.


 


1.21         
“Confidential Information” shall mean all secret, confidential, non-public or proprietary Know-How, whether
provided in written, oral, graphic, video, computer or other form, provided by or on behalf of one Party to the other Party pursuant
to this Agreement, including information relating to the disclosing Party’s existing or proposed research, development efforts,
patent applications or business and any other materials that have not been made available by the disclosing Party to the general
public. All such information related to this Agreement disclosed by or on behalf of a Party (or its Affiliate) to the other Party
(or its Affiliate) pursuant to the Confidential Disclosure Agreement shall be deemed to be such Party’s Confidential Information
disclosed hereunder. For purposes of clarity, (i) Sandoz’s Confidential Information shall include all Product Materials,
(ii) the terms of this Agreement shall be considered Confidential Information of both Parties, and (iii) RareGen Property shall
be considered Confidential Information of RareGen.


 


1.22         
“Detail(s)” shall mean a full Product presentation during a Promotional Call between a Target Professional
and a Sales Representative, during which a presentation of the Product’s attributes, benefits, prescribing information and
safety information are orally presented in a fair and balanced manner, for use in the Field in the Territory. Neither e-details,
nor presentations made at conventions, exhibit booths, educational programs or speaker meetings, or similar gatherings, shall constitute
a Detail.


 


1.23         
“Detail Numbers” shall mean the actual number of Details, broken-down by Sales Representative, made in
a given period for conduct of RareGen Activities for the Product as tracked by the internal systems (with respect to which accurate
reports can be kept) of RareGen as customarily used in the pharmaceutical industry.


 


1.24         
“Detail Report” shall have the meaning set forth in Section 4.2.3(a).


 


1.25         
“Dispute” shall have the meaning set forth in Section 13.7.1.


 


1.26         
“Dollar” or “$” shall mean United States dollar.


 


1.27         
“Effective Date” shall have the meaning set forth in the preamble to this Agreement.


 


1.28          “Exclusivity
Period” shall mean that period commencing on the Effective Date and continuing until the later of (i) the
expiration of the period during which Sandoz has generic drug exclusivity under the ANDA, and (ii) the first sale (other than
the First Commercial Sale by Sandoz or the sale of an authorized generic by a Third Party) for monetary value for use or
consumption by the end user of a generic version of Remodulin® in the Territory after regulatory approval for such
product has been obtained in the Territory.


 






     4


     


    

 


1.29         
“Failure to Supply Event” or “FTS Event” shall mean the occurrence of any of the following
events: (a) Sandoz’s failure to achieve the Quality Release Milestone on or before March 1, 2019; or (b) the
occurrence of a Recall of the Product with respect to [***] percent ([***]%) or more of the Quality Release Milestone Units; provided
that such Recall of the Product is not due to a breach of this Agreement by RareGen.


 


1.30         
“FDA” shall mean the United States Food and Drug Administration or any successor agency performing comparable
functions.


 


1.31         
“Field” shall mean the use of the Product for the treatment of pulmonary arterial hypertension.


 


1.32         
“Field Force Personnel” shall mean collectively, the Sales Representatives and any other employees (or
other permitted contractors) of RareGen engaged in the RareGen Activities or other activities hereunder.


 


1.33         
“Findings” shall have the meaning set forth in Section 5.3.


 


1.34         
“Firm Zone” shall have the meaning set forth in Section 2.7.1.


 


1.35         
“First Commercial Sale” shall mean, with respect to the Product, the first sale for monetary value for
use or consumption by the end user of the Product in the Territory.


 


1.36         
“Forecast” shall have the meaning set forth in Section 2.7.1.


 


1.37         
“Governmental Authority” shall mean any court, agency, authority, department, regulatory body or other
instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political
subdivision of any such government or any supranational organization of which any such country is a member, which has competent
and binding authority to decide, mandate, regulate, enforce, or otherwise control the activities of the Parties contemplated by
this Agreement.


 


1.38         
“HUB” shall mean a single point of contact for patient, physician and payors in coordination of patient
care management.


 


1.39         
“IFRS” shall mean International Financing Reporting Standards as generally and consistently applied by
Sandoz.


 


1.40         
“Indemnified Party” shall have the meaning set forth in Section 11.3.


 


1.41         
“Indemnifying Party” shall have the meaning set forth in Section 11.3.


 


1.42         
“Initial Term” shall have the meaning set forth in Section 12.1.


 


1.43         
“Intellectual Property” shall have the meaning set forth in Section 8.1.2.


 









     5


     


    

 



 


1.44         
 “Inventions” shall have the meaning set forth in Section 8.1.2.


 


1.45         
“JSC” shall have the meaning set forth in Section 3.1.


 


1.46         
“Know-How” shall mean information, whether or not in written form, including biological, chemical, pharmacological,
toxicological, medical or clinical, analytical, quality, manufacturing, research, or sales and marketing information, including
processes, methods, procedures, techniques, plans, programs and data.


 


1.47         
“Losses” shall mean any and all amounts paid or payable to Third Parties with respect to a Claim, together
with all documented out-of-pocket costs and expenses, including attorney’s fees, reasonably incurred in connection with any
judgments, orders, decrees, stipulations and/or injunctions that arise out of a Claim.


 


1.48         
“Managed Care Entity” shall mean (i) any entity providing pharmacy management or formulary services
either directly to members of plans controlled by the entity or indirectly to plans under contract with the entity and in either
case which has in place systems to actively manage the selection of prescription product usage; (ii) any agency of the United States
government; or (iii) any federal and/or state government funded pharmaceutical reimbursement program, such as a state Medicaid
program or program for pharmaceutical assistance to the elderly.


 


1.49         
“Manufacture”, “Manufactured” or “Manufacturing” shall mean the
manufacture and packaging of Product, including quality assurance activities related to manufacturing and release of Product.


 


1.50         
“Manufacturer Termination” shall have the meaning set forth in Section 12.3.2.


 


1.51         
“Minimum Order Quantity” shall mean the minimum order quantity of Product by SKU as set forth on Exhibit 1.51.


 


1.52         
“Net Profits” shall mean Net Sales less: (i) COGs with respect to the Product and/or Product Diluent
to the extent the Product and/or Product Diluent is manufactured by Sandoz or its Affiliates, (ii) Sandoz’s actual costs
with respect to the Product and/or Product Diluent to the extent that the Product and/or Product Diluent is manufactured on behalf
of Sandoz or its Affiliates by a Third Party, (iii) any Product or Product component write-offs resulting from or relating to Sandoz’s
inability to sell the Product in accordance with the Forecasts provided to Sandoz by RareGen, and (iv) the costs associated with
Patient Starter Kits, and (v) any and all fees, charges and expenses charged by or relating to any specialty pharmacy, distributor,
wholesaler, group purchasing organization or any Affiliate thereof that are not included for purposes of the calculation of Net
Sales.


 






    6 


     


    

 


1.53         
“Net Sales” shall mean the net sales recorded by Sandoz or any of its Affiliates (or any Third Party
granted any rights to sell Products in the Territory under the ANDA) for any Product sold to Third Parties as determined in accordance
with IFRS as consistently applied. The deductions booked on an accrual basis by Sandoz and its Affiliates under IFRS to calculate
the recorded net sales from gross sales include the following (without duplication and solely to the extent consistent with IFRS):


 


1.53.1   
 normal trade and cash discounts;


 


1.53.2   
amounts repaid or credited by reasons of defects, rejections, recalls or returns;


 


1.53.3   
price protection and shelf stock adjustments, slotting fees and coupons;


 


1.53.4   
rebates and chargebacks to customers and third parties (including, without limitation, Medicare, Medicaid, Managed Healthcare
and similar types of rebates);


 


1.53.5   
any amounts recorded in gross revenue associated with goods provided to customers for free;


 


1.53.6   
amounts provided or credited to customers through coupons and other discount programs;


 


1.53.7   
delayed ship order credits, discounts or payments related to the impact of price increases between purchase and shipping
dates or retroactive price reductions;


 


1.53.8   
fee for service payments to customers for any non-separable services (including compensation for maintaining agreed inventory
levels and providing information); and


 


1.53.9   
other reductions or specifically identifiable amounts deducted as customary in the pharmaceutical industry.


 


With respect to the calculation of Net
Sales: (i) Net Sales only include the value charged or invoiced on the first arm’s length sale to a Third Party and
sales between or among Sandoz and its Affiliates shall be disregarded for purposes of calculating Net Sales; and (ii) if a Product
is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated at the time all the revenue
recognition criteria under IFRS are met.


 


To the extent any of the foregoing are
based upon estimates in any given accounting period, any changes in such estimates shall be applied (and, if applicable, credited)
in the accounting period in which such changes are made, in accordance with IFRS.


 


Subject to the above, Net Sales shall be
calculated in accordance with the standard internal policies and procedures of Sandoz, which must be in accordance with IFRS, consistently
applied, to the maximum extent consistent with the foregoing. Example calculations of the itemized deductions booked on an accrual
basis by Sandoz and its Affiliates under IFRS to calculate the recorded net sales from gross sales pursuant to this Section 1.53
are set forth on Exhibit 1.53 for illustrative purposes only; provided, however, that Exhibit 1.53 sets forth the initial
reserves that Sandoz will use unless and until such reserves are adjusted in accordance with IFRS.


 


1.54         
“Officials” shall have the meaning in Section 4.5.3.


 


1.55         
“Party” shall have the meaning set forth in the preamble to this Agreement.


 






    7 


     


    

 


1.56         
 “Patient Starter Kit” shall mean a supply of Product provided to a patient free of charge, by or on
behalf of a prescribing health care professional in order to initiate treatment with the Product prior to the initial sale of Product
to (or for use by) a patient (e.g., while awaiting proper approval, following prescription by a health care professional, by the
payor (e.g., insurance company, managed care plan, government agency, or the like) with respect to all or any portion of the cost
of the Product)).


 


1.57         
“Payment” shall have the meaning set forth in Section 4.5.3.


 


1.58         
“Person” shall mean any individual, corporation, partnership, limited liability company, association,
joint-stock company, trust, unincorporated organization or other entity, or government or political subdivision thereof.


 


1.59         
“Pharmacovigilance Agreement” shall have the meaning set forth in Section 5.4.


 


1.60         
“Product” shall mean treprostinil (therapeutic equivalent to Remodulin®) in those doses set forth
on Exhibit 1.51, in each case, as approved by the FDA for sale in the United States under the ANDA; provided, however,
that in the event Sandoz obtains approval under the ANDA for treprostinil (therapeutic equivalent to Remodulin®) in doses other
than those set forth on Exhibit 1.51, RareGen and Sandoz shall amend this Agreement as may be reasonably necessary
to include such other doses.


 


1.61         
“Product Diluent” shall mean 50 ml vials of treprostinil sterile diluent.


 


1.62         
“Product Labeling” shall mean the labels and other written, printed or graphic matter upon (a) any
container or wrapper utilized with the Product or (b) any written material accompanying the Product, including Product package
inserts, in each case as approved by the FDA.


 


1.63         
“Product Materials” shall mean the Product Training Materials, the RareGen Activity Materials and/or
any other Product materials provided by or on behalf of Sandoz (or provided by RareGen and approved by Sandoz, as applicable) hereunder
for use in connection with the conduct of the RareGen Activities for the Product.


 


1.64         
“Product Training Materials” shall have the meaning set forth in Section 4.6.1(a).


 


1.65         
“Profit Margin Deficiency” shall have the meaning set forth in Section 12.3.3.


 


1.66         
“Promotional Call” shall mean a face-to-face sales call between a Target Professional and a Sales Representative,
during which a Detail is made. A sample drop shall not constitute a Promotional Call.


 


1.67         
“Quality Agreement” shall have the meaning set forth in Section 5.2.2.


 


1.68         
“Quality Release Milestone” shall have the meaning set forth in Section 6.2.


 


1.69         
“Quality Release Milestone Units” shall have the meaning set forth in Section 6.2.


 






    8 


     


    

 


1.70         
 “RareGen” shall have the meaning set forth in the preamble to this Agreement.


 


1.71         
“RareGen Activities” shall mean any and all promotional and non-promotional activities (including Detailing)
to encourage the appropriate use of the Product in the Field in the Territory in accordance with the Product Labeling and Applicable
Law. For the sake of clarity, examples of RareGen Activities other than Detailing are set forth on Exhibit 1.71.


 


1.72         
“RareGen Activity Materials” shall have the meaning set forth in Section 4.6.2.


 


1.73         
“RareGen Activity Plan and Budget” shall have the meaning set forth in Section 4.2.2(a).


 


1.74         
“RareGen Opportunity Transaction” shall have the meaning set forth in Section


 


1.75         
“RareGen Property” shall have the meaning set forth in Section 8.1.1.


 


1.76         
“Recall” shall mean (i) a Recall (as defined in the Act) assigned a classification by the FDA with
numerical designation I, II or III (each as defined in the Act), or (ii) a Stock Recovery (as defined in the Act) due to the failure
of the affected Product to meet the Specifications and where the Quality Release Milestone Units that are the subject of such Stock
Recovery cannot be replaced by Sandoz on a timely basis with new units of Product, which have achieved successful quality release
as evidenced by a Certificate of Analysis, in order to meet in all material respects the then-current orders for Product.


 


1.77         
“Regulatory Approval” shall mean any and all necessary approvals, licenses, registrations or authorizations
from any Governmental Authority, in each case, necessary to commercialize the Product in the Territory.


 


1.78         
“Sales and Inventory Report” shall have the meaning set forth in Section 4.2.3(b).


 


1.79         
“Sales Representative” shall mean an individual employed by RareGen as part of its sales forces who actively
engages in Detailing of the Product in the Territory, and who is also trained with respect to the Product in accordance with this
Agreement (including the Product Labeling and the use of the RareGen Activity Materials) to deliver Details for the Product in
the Field in the Territory.


 


1.80         
“Sandoz” shall have the meaning set forth in the preamble to this Agreement.


 


1.81         
“Sandoz Trademarks and Copyrights” shall mean the logos, trade dress, slogans, domain names and housemarks
of Sandoz or any of its Affiliates as may appear on any RareGen Activity Materials, Product Training Materials or Product Labeling,
in each case, as may be updated from time to time by Sandoz.


 


1.82         
“Senior Officer” shall mean, with respect to Sandoz, its President, Head of North America (or such officer’s
designee), and with respect to RareGen, the individual designated by the Board of Directors of RareGen.


 






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1.83         
 “Specifications” shall mean the technical specifications for the required quality and characteristics
of the Product as accepted by the FDA.


 


1.84         
“Target Professionals” shall mean physicians, nurse practitioners, physician assistants and any other
medical professionals in the Territory with prescribing authority (as authorized under Applicable Law) in the Territory for the
Product. For the avoidance of doubt, Managed Care Entities shall not be considered Target Professionals.


 


1.85         
“Term” shall have the meaning set forth in Section 12.1.


 


1.86         
“Territory” shall mean the United States of America, its commonwealths, territories, possessions (e.g.,
Puerto Rico, US Virgin Islands, Guam, American Samoa) and military bases.


 


1.87         
“Third Party(ies)” shall mean any person or entity other than Sandoz and RareGen and their respective
Affiliates.


 


ARTICLE 2

RIGHTS AND OBLIGATIONS


 


2.1             
Engagement; Grant of Rights. During the Term, subject to the terms and conditions of this Agreement, Sandoz
hereby engages and retains RareGen, on an exclusive basis, to conduct the RareGen Activities for the Product in the Territory in
the Field in compliance with the Product Labeling, and RareGen shall conduct the RareGen Activities for the Product in the Territory
in the Field in compliance with the Product Labeling, Applicable Laws and otherwise in accordance with the terms and conditions
of this Agreement, and shall use its Commercially Reasonable Efforts to conduct the RareGen Activities for the Product in the Territory
in the Field in compliance with the RareGen Activity Plan and Budget. RareGen shall have no other rights relating to the Product,
except as specifically set forth in this Agreement, and, without limiting the foregoing, RareGen shall have no right to, and shall
not, conduct the RareGen Activities for the Product outside the Territory or for use outside the Field, in each case, unless mutually
agreed in writing by the Parties.


 


2.2             
Retention of Rights. Except with respect to the exclusive rights granted to RareGen to conduct the RareGen
Activities for the Product in the Territory in the Field pursuant to Section 2.1, Sandoz retains all rights in and to the
Product. Without limiting the generality of the foregoing, Sandoz specifically retains, and shall bear all costs associated with,
the following rights (and RareGen and its Affiliates shall have no rights to the following, except as set forth below in this Section 2.2):


 


2.2.1       
responsibility for the specifications for the Product, for the manufacture and distribution of the Product, and any future
development of the Product;


 


2.2.2       
responsibility for all decisions regarding regulatory submissions and for interactions with the FDA with respect to the
Product;


 






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2.2.3       
 responsibility for final approval of all RareGen Activity Material content (including submission of RareGen Activity Materials
to the FDA’s Office of Prescription Drug Promotion) with respect to the conduct of the RareGen Activities for Product;


 


2.2.4       
contracting with Managed Care Entities or customers for Product in accordance with Section 4.10;


 


2.2.5       
selling and booking all sales of the Product in accordance with IFRS; and


 


2.2.6       
responsibility for handling all safety related activities related to Product as set forth in ARTICLE 5 (including submitting
all safety reports and interacting with regulatory authorities with respect thereto) and initiating and managing any Product recalls.


 


For clarity, except as provided in Sections 2.1
or 2.5, RareGen shall not acquire any license or other intellectual property interest, by implication or otherwise, in any technology,
Know-How or other intellectual property owned or controlled by Sandoz or any of its Affiliates, and Sandoz is not providing any
such technology, Know-How or other intellectual property, or any assistance related thereto, to RareGen for any use other than
for the mutual benefit of the Parties as expressly contemplated hereby.


 


2.3             
Right of Notice. In the event that, during the Initial Term, Sandoz desires to partner the conduct of the
RareGen Activities for the Product outside of the Territory (“RareGen Opportunity Transaction”), Sandoz shall
first provide RareGen with written notice of its desire to enter into a RareGen Opportunity Transaction in order to allow the Parties
the opportunity to discuss in good faith amending this Agreement or entering into a separate agreement with respect to such activities.
Such notice shall be for the purpose of providing an opportunity for discussions regarding the RareGen Opportunity Transaction
and shall not create any rights of RareGen in such opportunity or obligations of Sandoz with respect thereto. RareGen shall not
have a right of first refusal or right of first negotiation with respect to such RareGen Opportunity Transaction, and Sandoz may
negotiate with any other Person and take any and all actions with respect to the Product outside of the Territory. For clarity,
RareGen Opportunity Transaction shall not include Sandoz’s desire to partner the conduct of RareGen Activities for the Product
outside the Territory with a Third Party as part of a broader partnership to develop, seek regulatory approval for, and/or commercialize
the Product outside the Territory.


 


2.4             
Non-Competition; Non-Solicitation.


 


2.4.1       
Non-Competition. Without limiting the obligations of RareGen set forth in Section 4.7.1(a), during the Term,
neither RareGen nor Sandoz shall, directly or indirectly, market, promote, detail, offer to sell or sell any prostacyclin product
in the Field in the Territory other than the Product.


 


2.4.2        Non-Solicitation.
During the Term and continuing thereafter for [***] ([***]) months, neither RareGen (nor PBM Capital Group, LLC or PBM
Pharmaceuticals, Inc.) nor Sandoz shall directly or indirectly solicit for hire as an employee, consultant or otherwise any
of the other Party’s professional personnel who have had direct involvement with the RareGen Activities under this
Agreement, without the other Party’s prior written consent, except pursuant to a general solicitation through the media
or by a search firm, in either case, that is not directed specifically to any such professional personnel.


 






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2.5             
Sandoz Trademarks and Copyrights.


 


2.5.1       
RareGen shall have the non-exclusive right to use the Sandoz Trademarks and Copyrights solely on the Product Labeling and
Product Materials and solely in accordance with the terms and conditions of this Agreement. Except as expressly set forth in the
foregoing provisions of this Section 2.5.1, RareGen shall not have the right to use any trademarks or copyrights of Sandoz
or any of its Affiliates unless RareGen obtains the prior written consent of Sandoz, in Sandoz’s sole discretion. Sandoz
agrees to promptly provide to RareGen as many copies of the current Product Labeling as may be necessary for RareGen’s use
solely to perform its obligations under this Agreement. Sandoz shall promptly notify RareGen of any final approved updates or changes
to the Product Labeling and provide a copy of such final approved changes/updates to RareGen within thirty (30) days after
approval thereof, solely for RareGen’s use to perform its obligations under this Agreement, and RareGen shall thereafter
use such updated Product Labeling in performing its obligations under this Agreement.


 


2.5.2       
RareGen shall follow all instructions and guidelines of Sandoz in connection with the use of any Sandoz Trademarks and Copyrights,
and, if Sandoz objects to the manner in which any such Sandoz Trademarks and Copyrights are being used, RareGen shall cease the
use of any such Sandoz Trademarks and Copyrights in such manner upon written notice from Sandoz thereof. Without limiting the foregoing,
RareGen shall also adhere to at least the same quality control provisions as companies in the pharmaceutical industry adhere to
for their own trademarks and copyrights. In all cases, RareGen shall use the Sandoz Trademarks and Copyrights with the necessary
trademark (and copyright, as applicable) designations, and shall use the Sandoz Trademarks and Copyrights in a manner that does
not derogate from Sandoz’s rights in the Sandoz Trademarks and Copyrights. RareGen shall not at any time during the Term
do, or knowingly allow to be done, any act or thing which will in any way impair or diminish the rights of Sandoz in or to the
Sandoz Trademarks and Copyrights. All goodwill and improved reputation generated by RareGen’s use of the Sandoz Trademarks
and Copyrights shall inure to the benefit of Sandoz, and any use of the Sandoz Trademarks and Copyrights by RareGen shall cease
at the end of the Term. RareGen shall have no rights under this Agreement in or to the Sandoz Trademarks and Copyrights except
as specifically provided herein. RareGen will not, and will cause PBM Capital Group, LLC and PBM Pharmaceuticals, Inc. not to,
contest the ownership of the Sandoz Trademarks and Copyrights, their validity, or the validity of any registration therefor during
the Term or thereafter. RareGen will not, and will cause PBM Capital Group, LLC and PBM Pharmaceuticals, Inc. not to, register
and/or use any marks (including in connection with any domain names) that are confusingly similar to the Sandoz Trademarks and
Copyrights.


 


2.6              Subcontracting.
RareGen may not subcontract with any Affiliate or any Third Party (including any contract sales force) unless RareGen has
received the prior written consent of Sandoz (not to be unreasonably withheld); provided, however, that RareGen shall have
the right to subcontract with PBM Capital Group, LLC and PBM Pharmaceuticals, Inc. pursuant to fully executed written
agreements between RareGen and such Affiliates without any further consent of Sandoz. In all cases, RareGen shall oversee the
performance by its subcontractors of the subcontracted activities in a manner intended to result in their timely and
successful completion of such activities, and RareGen shall remain responsible and primarily and fully liable for the
performance of such activities, in accordance with this Agreement. RareGen hereby expressly waives any requirement that
Sandoz exhaust any right, power or remedy, or proceed against such subcontractor for any obligation or performance hereunder
prior to proceeding directly against RareGen. RareGen shall ensure compliance with the terms of this Agreement by any such
subcontractor, including with respect to provisions on confidentiality and intellectual property ownership and compliance
with Applicable Law, and RareGen shall further ensure compliance by any such subcontractor with RareGen’s customary
policies. For clarity, RareGen shall not have any license rights hereunder nor any rights to sublicense any rights
hereunder.


 






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2.7             
Obligation to Manufacture and Supply.


 


2.7.1       
Product and Product Diluent. Sandoz shall be solely responsible for Manufacturing (or having Manufactured),
and agrees to use Commercially Reasonable Efforts to supply, all Product and Product Diluent for commercial use in the Field in
the Territory in accordance with the Specifications; provided that RareGen shall provide reasonable assistance in identifying a
source of supply for Product Diluent. On or before the tenth (10th) day of each month after the Effective Date, RareGen shall provide
Sandoz a good faith twenty-six (26)-month rolling forecast of anticipated orders of the Product and Product Diluent to be placed
each such month (each, a “Forecast”). The first four (4) months of each Forecast will be considered a firm
and binding order (“Firm Zone”); provided, however, that such orders will not be firm and binding where the
quantity of Product or Product Diluent provided in any Firm Zone is less than the Minimum Order Quantity. For components obtained
from Third Parties with longer lead times than the Firm Zone, Sandoz will place orders with Third Parties based on the Forecast.
In relation to each Forecast provided under this Section 2.7.1, RareGen shall ensure that the aggregate amount of the Product
or Product Diluent forecasted for the first twelve (12) months of each Forecast shall not be less than eighty percent (80%)
or more than one hundred and twenty percent (120%) of the aggregate amount of the Product or Product Diluent, respectively, in
the first twelve (12) months in the immediately preceding Forecast. If RareGen submits a Forecast where the aggregate amount
of the Product or Product Diluent forecasted for the first twelve (12) months of such Forecast is more than one hundred and
twenty percent (120%) of the aggregate amount of the Product or Product Diluent, respectively, in the first twelve (12) months
in the immediately preceding Forecast, RareGen and Sandoz will discuss in good faith potential means to obtain the supply of such
greater amount of Product or Product Diluent, as the case may be, for commercial use in the Field in the Territory.


 


2.7.2       
Annual Maximum Quantity. RareGen acknowledges and agrees that during the Term, Sandoz shall only be under
an obligation to supply the Product and Product Diluent in any one Calendar Year (including any Product supplied for Patient Starter
Kits) up to the Annual Maximum Quantity as specified in Exhibit 2.7.2 (or the pro-rated Annual Maximum Quantity, if
applicable) and only if that Annual Maximum Quantity was properly forecasted by RareGen. Sandoz shall not be required and is under
no obligation to supply the Product and Product Diluent in any one Calendar Year in excess of the Annual Maximum Quantity. Following
the 2019 Calendar Year, Sandoz shall use Commercially Reasonable Efforts to increase the Annual Maximum Quantity if, and to the
extent, required due to increases in demand of the Product for commercial use in the Field in the Territory.


 






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2.7.3       
 Safety Stock. For the first eighteen (18) months following the Effective Date, subject to the approval
of the JSC, Sandoz shall maintain the difference between the total number of units of Product set forth in each Firm Zone during
such eighteen-month period and the total number of units of Product actually supplied by Sandoz in accordance with each such Firm
Zone as safety stock of Product available to Sandoz; provided, however, that in no event shall such safety stock exceed twenty
percent (20%) of the Annual Maximum Quantity for the 2019 Calendar Year. Sandoz shall keep RareGen reasonably informed of the level
of inventory identified as the safety stock.


 


2.8             
Facility Maintenance; Product Quality Matters.


 


2.8.1       
Sandoz shall maintain and operate, or exercise its rights with its contract manufacturer or other contractors to cause such
contractors to maintain and operate, all facilities where the Product is manufactured, packaged, tested, stored, warehoused or
shipped, and implement such quality control procedures so as to be able to perform its obligations hereunder, in accordance with
all Applicable Laws, including the cGMP Requirements. Sandoz will audit the supplier in accordance with the standard operating
procedures of Sandoz or its Affiliates, as applicable.


 


2.8.2       
Sandoz shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering
quality control testing and release of the Product and all other Manufacturing services provided hereunder in material compliance
with the cGMP Requirements and any other relevant Applicable Laws, but in any event during the performance of the Manufacturing
services.


 


2.8.3       
Sandoz shall as soon as reasonably practicable notify RareGen of any written notices received from, or inspections by, the
FDA, which (i) materially affect the safety or efficacy of, or Sandoz’s ability to supply, the Product or (ii) relate
specifically to the conduct of the RareGen Activities for the Product. In each such case, Sandoz shall make all such records available
to FDA as required by Applicable Laws. Sandoz shall promptly inform RareGen of any responses to such written notices or inspections
and the resolution of any such issue raised by the FDA.


 


ARTICLE 3

GOVERNANCE


 


3.1              Formation
of the JSC. As soon as practicable, but no later than twenty (20) days after the Effective Date, the Parties
shall form a joint steering committee (“JSC”) whose responsibilities during the Term shall be to oversee
the activities set forth in Section 3.4. The JSC shall consist of three (3) representatives from each Party, each
with the requisite seniority to enable such person to make decisions on behalf of the Parties with respect to issues falling
within the jurisdiction of the JSC (which representatives, in the case of Sandoz, shall (i) be employees of Sandoz and
(ii) not provide any information received through the JSC, that sets forth the identity of or contact information for Sales
Representatives, to Affiliates of Sandoz). From time to time, each Party may change any of its representatives on the JSC by
giving written notice to the other Party. The meetings will be chaired by a representative from Sandoz. The JSC shall
determine a meeting schedule; provided, that, in any event, meetings shall be conducted no less frequently than quarterly by
teleconference or in person, or as otherwise agreed by the Parties. During the Exclusivity Period, such meetings shall be
conducted no less frequently than monthly.


 






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3.2             
Meetings and Minutes. Meetings of the JSC may be called by either Party on no less than thirty (30) days’
notice during the Term and on no less than ten (10) days’ written notice during the Exclusivity Period. Each Party shall
make all proposals for agenda items and shall provide all appropriate information with respect to such proposed items at least
ten (10) days in advance to the applicable meeting; provided that under exigent circumstances requiring input by the JSC,
a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting, or may propose
that there not be a specific agenda for that particular meeting, so long as the other Party consents to such later addition of
such agenda items or the absence of a specific agenda for such meeting, such consent not to be unreasonably withheld. The chairperson
shall prepare and circulate for review and approval of the Parties minutes of each meeting within thirty (30) days after the
meeting.


 


3.3             
Procedural Rules. The JSC shall have the right to adopt such standing rules as shall be necessary for its
work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JSC shall exist whenever there is
present at a meeting at least one (1) representative appointed by each Party. The JSC shall take action by consensus of the
representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number
of representatives of such Party in attendance, or by a written resolution signed by at least one (1) representative appointed
by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend meetings
of the JSC; provided, that such attendees (i) shall not vote or otherwise participate in the decision-making process of the
JSC, and (ii) are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in ARTICLE 9.


 


3.4             
Specific Responsibilities of the JSC. The purposes of the JSC shall be to, subject to Section 3.5:


 


3.4.1       
review and approve annual or more frequent updates or amendments to the RareGen Activity Plan and Budget for the Territory
as contemplated by Section 4.2.2(b);


 


3.4.2       
discuss planning and implementation of all RareGen Activities under the RareGen Activity Plan and Budget, including training
and Detail Numbers and alignment within the Territory;


 


3.4.3       
discuss planning and implementation of pricing strategies with payers under the RareGen Activity Plan and Budget;


 


3.4.4       
discuss overall commercialization strategy and implementation thereof;


 


3.4.5       
discuss the forecasting (including the establishment and maintenance of a safety stock), procurement and manufacture of
the Product and constituent parts thereof, including Product Diluent, and cost saving strategies;


 


3.4.6        discuss
the performance of suppliers (including with respect to quality) under any supply agreements that relate to the Product and
constituent parts thereof, including Product Diluent, and discuss the general and applicable terms of any such supply
agreements or any proposed changes thereto;


 






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3.4.7       
discuss status and terms of agreements with customers, including pricing terms;


 


3.4.8       
discuss items that are included in the calculation of Net Profits, Net Sales and COGS, including the items identified in
Sections 1.53.1 through 1.53.9; and


 


3.4.9       
perform such other responsibilities as may be mutually agreed upon by the Parties in writing from time to time; provided,
however, that the JSC shall have no authority to amend any provisions of this Agreement.


 


3.5             
JSC Dispute Resolution.


 


3.5.1       
If the JSC does not reach consensus on an issue at a meeting or within a period of thirty (30) days thereafter, then
the JSC shall submit in writing the respective positions of the Parties to the Senior Officers of the Parties. Such Senior Officers
shall use good faith efforts to resolve promptly such matter, which good faith efforts shall include at least one (1) teleconference
between such Senior Officers within ten (10) days after the JSC’s submission of such matter to them. Any final decision
mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to
agree on the resolution of any such issue within thirty (30) days after such issue was first referred to them, then:


 


(a)              
except where specifically allocated in clauses (b) or (c) of this Section 3.5.1, disputes arising between
the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and
that are within the provisions of this ARTICLE 3, shall require mutual, unanimous agreement of the Parties’ representatives
to the JSC. If the Parties are unable to mutually agree on any such matter, then neither Party shall have the right to resolve
the matter over the objection of the other Party, the matter shall remain unresolved unless and until agreed upon by the JSC, and
the decision most recently approved by the JSC with respect to such dispute shall remain in force and effect without such amendment
or change.


 


(b)              
except where specifically allocated in clause (c) of this Section 3.5.1, if such dispute relates to the RareGen
Activity Plan and Budget or the approval of any proposed updates or amendments to the RareGen Activity Plan and Budget, then such
dispute shall be finally and definitively resolved by the Senior Officer of RareGen; provided that, in all cases, the RareGen Activities
are subject to any consent of Sandoz required pursuant to Section 4.4.


 


(c)              
if such dispute is related to (i) manufacturing, any forecast that deviates from the requirements of Section 2.7,
development, supply or regulatory activities directed to the Product or the Parties’ activities hereunder, or (ii) contracting
with Managed Care Entities or other customers in the Territory (except with respect to matters specifically relating to pricing
decisions relating to such customers in the Territory) or fulfillment of sales of the Product, then in any such case such dispute
shall be finally and definitively resolved by the Senior Officer of Sandoz.


 






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3.5.2       
 Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered
in connection herewith, and that are outside the provisions of this ARTICLE 3, shall be resolved pursuant to Section 13.7.


 


ARTICLE 4

RAREGEN ACTIVITIES FOR PRODUCT


 


4.1             
RareGen Activities. RareGen will use Commercially Reasonable Efforts to conduct the RareGen Activities for
the Product in the Field in the Territory in accordance with the RareGen Activity Plan and Budget. Without limiting the generality
of the foregoing, RareGen will (i) use Commercially Reasonable Efforts to establish and maintain its Field Force Personnel
at levels sufficient to effectively conduct the RareGen Activities for the Product in the Field in the Territory and to maximize
the long-term and short-term profitability with respect to Product sold in the Territory, and (ii) educate and support Target Professionals
with respect to the benefits of the use of the Product in the Field. During the last Calendar Year of the Initial Term or any applicable
renewal period, RareGen shall not reduce its then current level of performance of its conduct of the RareGen Activities unless
the RareGen Activity Plan and Budget has been so amended and updated.


 


4.2             
Detailing.


 


4.2.1       
General. Commencing promptly after the Effective Date, and upon completion of RareGen’s training and
certification of the Sales Representatives on the Product as set forth in Section 4.6.1, RareGen shall deploy its Sales Representatives
to Detail the Product in the Territory for use in the Field in accordance with the RareGen Activity Plan and Budget and the terms
of this Agreement, as well as the Product Labeling and the training given to such Sales Representatives by RareGen. Upon receipt
of approval of the Product Labeling as well as Product Training Materials from Sandoz hereunder, RareGen shall promptly train and
certify its Field Force Personnel in accordance with this Agreement. Sales Representatives shall not engage in any direct discussions
or interactions with specialty pharmacies that would violate either (i) Applicable Laws or (ii) any guidelines that may be
adopted by the JSC from time to time.


 


4.2.2       
Target Professionals and Detail Requirements.


 


(a)               The
strategy for RareGen Activities of the Product in the Territory will be set forth in an annual detailing and targeting plan
and budget (the “RareGen Activity Plan and Budget”), which will be used as the basis for the RareGen
Activities to be undertaken under this Agreement. RareGen shall develop, at its cost and expense, and propose for JSC
approval, the RareGen Activity Plan and Budget, which plan shall include an estimate of the Detail Numbers for the Product
within the Territory, an estimated minimum number of Details, key performance indicators, the structure of Sales
Representative compensation, an associated budget, the initial pricing of the Product and pricing strategy, and other
information the JSC reasonably believes necessary for the successful conduct of RareGen Activities for the Product in the
Territory. Notwithstanding the foregoing, during the Exclusivity Period, the RareGen Activity Plan and Budget shall be a
monthly plan and budget. The initial RareGen Activity Plan and Budget is attached hereto as Exhibit 4.2.2.
Subject to compliance with the other terms of this Agreement, RareGen shall reasonably allocate the Details among potential
Target Professionals taking into consideration geographic territory, frequency of calls, prescribing levels and other
reasonable considerations; provided, however, that RareGen shall take into consideration those Target Professionals
responsible for treating the greatest number of potential patients for the Product in the Field, and RareGen shall employ its
expertise, best professional judgment and, where applicable, its working relationships with the Target Professionals, to
ensure that the Sales Representatives Detail the Product in the Field in the Territory to Target Professionals.


 






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(b)              
RareGen shall, at its cost and expense, prepare and propose on an annual basis (no later than June 30 of the preceding
Calendar Year), and provide to the JSC for approval, an updated RareGen Activity Plan and Budget covering the following Calendar
Year. The JSC will approve the updated RareGen Activity Plan and Budget by August 31 of the preceding Calendar Year. Notwithstanding
the foregoing, during the Exclusivity Period, RareGen shall, at its cost and expense, prepare and propose on a monthly basis (no
later than five (5) days prior to the end of the preceding month), and provide to the JSC for approval, an updated RareGen
Activity Plan and Budget covering the following month.


 


4.2.3       
Reports.


 


(a)              
Within fifteen (15) days following the end of (i) each month during the Exclusivity Period, (ii) each Calendar
Quarter during the Term, and (iii) each Calendar Year during the Term, RareGen shall provide Sandoz with a written report (each
a “Detail Report”) summarizing RareGen’s activities pursuant to this Agreement for such month (or Calendar
Quarter or Calendar Year, as applicable). Each Detail Report will include information regarding the Details for the Product made
by its Sales Representatives in the Territory during such month (or Calendar Quarter or Calendar Year, as applicable). Such report
will include the Detail Numbers for the Product by territory within the Territory.


 


(b)              
Within fifteen (15) days following the end of (i) each month during the Exclusivity Period, (ii) each Calendar
Quarter during the Term, and (iii) each Calendar Year during the Term, Sandoz shall provide RareGen with a written report (each
a “Sales and Inventory Report”) providing information regarding Product inventory by SKU (at warehouse) and
Product sales by customer.


 


(c)              
Sandoz shall provide RareGen with such sales, inventory and prescription information with respect to the Product as and
when such information may be provided or made available to Sandoz by any specialty pharmacy to the extent that such information
can be provided by Sandoz to RareGen without breach of any obligation to such specialty pharmacy. Sandoz shall use commercially
reasonable efforts to secure from any such specialty pharmacy the right to share with RareGen all information that is made available
by such specialty pharmacy to Sandoz.


 


4.3              Patient
HUB. Following the Effective Date, if a HUB is provided directly or indirectly by any specialty pharmacy,
distributor, wholesaler, group purchasing organization through whom the Product is distributed or any Affiliate thereof, then
the costs and expenses incurred in connection with such activities will deducted from Net Profits to the extent not already
deducted from Net Sales. If a HUB is not provided directly or indirectly by any specialty pharmacy, distributor, wholesaler,
group purchasing organization through whom the Product is distributed or any Affiliate thereof and if the Parties mutually
agree that such a HUB should be established, the Parties shall either (i) establish and maintain a HUB, and perform
related services with respect thereto, or (ii) engage a Third Party to perform HUB related services, in either case, to
effectively conduct the RareGen Activities for the Product in the Field in the Territory. If a HUB is established in
accordance with the preceding sentence, all costs and expenses incurred in connection with such activities will be excluded
from the calculation of Net Profits, and the Parties shall each bear fifty percent (50%) of all such costs and expenses.


 






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4.4             
Prohibition on Other RareGen Activities; Final Decision Making Authority. Notwithstanding anything to the
contrary in this Agreement, without the prior written consent of Sandoz (in its sole discretion), RareGen shall not conduct any
RareGen Activities (other than Detailing) with respect to the Product unless expressly agreed to by Sandoz in writing, and Sandoz
shall have final decision-making authority (in its sole discretion) with respect to all RareGen Activities related to the Product.
Without limiting the generality of the foregoing, Sandoz shall have the right (in its reasonable discretion and upon written notice
to RareGen) to cause RareGen to cease any particular RareGen Activity (and/or the manner of conducting a particular RareGen Activity)
with respect to the Product, and thereafter RareGen shall promptly cease such particular RareGen Activity (and/or the manner of
conducting a particular RareGen Activity), as applicable, with respect to the Product.


 


4.5             
Compliance with Applicable Law; Requirements.


 


4.5.1       
In conducting the RareGen Activities hereunder, RareGen shall, and shall require all Field Force Personnel to, comply in
all respects with Applicable Laws.


 


4.5.2       
Neither RareGen nor Sandoz shall offer, pay, solicit or receive any remuneration to or from Target Professionals, in order
to induce referrals of or purchase of the Product. RareGen, all Field Force Personnel and Sandoz shall comply with the Code, and
be trained in connection with compliance with Sec. 1128B(b) of the Social Security Act and the American Medical Association Ethical
Guidelines for Gifts to Physicians from Industry, prior to commencing any RareGen Activities.


 


4.5.3       
In performing the activities contemplated by this Agreement, neither RareGen nor Sandoz shall make any payment, either directly
or indirectly, of money or other assets (hereinafter collectively referred to as a “Payment”), to government
or political party officials, officials of international public organizations, candidates for public office, or representatives
of other businesses or persons acting on behalf of any of the foregoing (hereinafter collectively referred as “Officials”)
where such Payment would constitute violation of any Applicable Law. In addition, neither Party shall make any Payment either directly
or indirectly to Officials if such Payment is for the purpose of unlawfully influencing decisions or actions with respect to the
subject matter of this Agreement.


 


4.5.4       
RareGen agrees that it shall train any employee or agent of RareGen who is involved in performing the activities contemplated
by this Agreement on anti-corruption and anti-bribery at its own expense. Such training shall include the provisions of the applicable
anticorruption and anti-bribery laws and the standards set out in the Novartis Global Anti-Bribery Policy, found at http://www.novartis.com/corporate-responsibility/resources/index.shtml.


 






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4.5.5       
 No employee of RareGen or its Affiliates shall have authority to give any direction, either written or oral, relating to
the making of any commitment by such Party or its agents to any Third Party in violation of terms of this or any other provision
of this Agreement.


 


4.5.6       
Neither RareGen nor Sandoz shall undertake any activity under or in connection with this Agreement which violates any Applicable
Law.


 


4.5.7       
RareGen’s and Sandoz’s material failure to abide by the provisions of this Section 4.5 shall be deemed
a material breach of this Agreement and subject to the terms of Section 12.2 hereof.


 


4.6             
Field Force Personnel Training; Product Materials.


 


4.6.1       
Training and Training Materials.


 


(a)              
RareGen shall, at its cost and expense, prepare training materials with respect to the Product (the “Product Training
Materials”), and will train (or re-train, as may be reasonably appropriate, as applicable) the Field Force Personnel
with respect to the Product in accordance with customary practice in the pharmaceutical industry and otherwise in compliance with
this Agreement. RareGen shall provide all Product Training Materials to Sandoz for its prior written approval, not to be unreasonably
withheld. The Product Training Materials shall be provided by RareGen to Sandoz in advance of their proposed use by RareGen to
allow for Sandoz to review the content of such Product Training Materials, including with regard to the proper use of Sandoz Trademarks
and Copyrights, and provide feedback to RareGen in advance of RareGen’s use of such Product Training Materials. In the event
of any disagreement between the Parties regarding any feedback received from Sandoz with respect to such Product Training Materials,
RareGen shall not use such Product Training Materials and shall instead be limited to using other previously or subsequently accepted
Product Training Materials (unless Sandoz elects to update a previously accepted Product Training Material, in which case such
previously approved Product Training Material may not be used), if any, for purposes of training Field Force Personnel hereunder.
RareGen covenants that it shall use only Product Training Materials approved by Sandoz hereunder in the performance of such training
activities under this Agreement, and the content of such Product Training Materials shall not be modified or changed by RareGen
at any time without the prior written approval of Sandoz. RareGen may update “Overcoming Objections” with the Sales
Representatives without prior approval of Sandoz and all content must comply with Applicable Laws. Such Product Training Materials
may include, among other things, as determined by RareGen (and subject to Sandoz’s approval not to be unreasonably withheld),
training materials for Sales Representatives for Detailing the Product. RareGen will be responsible for its development, production
(including printing) and delivery costs of such Product Training Materials for the Field Force Personnel. RareGen will schedule
the delivery of Product Training Materials to allow sufficient internal and field force review time to accommodate regularly scheduled
training meetings. Training of the Field Force Personnel shall be RareGen’s sole responsibility (and at its sole cost and
expense).


 






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(b)               In
addition to the foregoing, RareGen shall prepare (and provide to Sandoz for its prior written approval pursuant to
Section 4.6.1(a)) Product Training Materials with respect to training RareGen’s speakers for promotional speaker
programs for the conduct of the RareGen Activities for the Product in the Field in the Territory and will train (or re-train,
as may be reasonably appropriate) such speakers with respect to the Product. Prior to conducting any such program, RareGen
shall require such speakers to complete specific training with respect to speaking on the Product. RareGen will be
responsible for its development, production (including printing) and delivery costs of such Product Training Materials for
such training. RareGen will schedule the delivery of training materials to allow sufficient internal and speaker review time
to accommodate regularly scheduled speaker training meetings. Such training shall be RareGen’s sole responsibility (and
at its sole cost and expense).


 


(c)              
From time to time throughout the Term, RareGen may update the Product Training Materials, in which case the provisions of
this Section 4.6.1 shall again apply with respect to training the relevant Field Force Personnel with respect to the updated
Product Training Materials in accordance with this Section 4.6.1.


 


(d)              
Field Force Personnel shall conduct the RareGen Activities for the Product only after having undergone such training and
certification (such certification applicable to Sales Representatives), and, without limiting the foregoing, no Sales Representative
shall Detail the Product without having undergone specific Detail training with respect to the Product. RareGen acknowledges and
agrees that, in order for an individual member of the Field Force Personnel to be deemed to have successfully completed the training,
such individual must demonstrate thorough knowledge of the medical and technical aspects of the Product and the use of the Product
in the Field, as well as applicable commercial practices policies (including Applicable Laws). Subject to the foregoing, RareGen
shall have the responsibility for on-going training of its Field Force Personnel in accordance with customary practice in the pharmaceutical
industry. At the request of Sandoz, RareGen shall furnish to Sandoz the certifications.


 


4.6.2        RareGen
Activity Materials. RareGen shall be responsible for developing the promotional message that is to be provided under
the RareGen Activities for the Product as well as other marketing and educational materials that relate to the delivery of
the RareGen Activities (collectively, the “RareGen Activity Materials”) that (a) are reasonably
necessary to support the RareGen Activities for the Product by RareGen and (b) are to be used by Field Force Personnel
in performing the RareGen Activities for the Product in accordance with this Agreement. All such RareGen Activity Materials
shall be prepared by RareGen, at its sole cost and expense, and shall comply with Applicable Laws and the Product Labeling,
and shall be subject to Sandoz’s prior written approval, not to be unreasonably withheld. The RareGen Activity
Materials shall be provided by RareGen to Sandoz in advance of their proposed use by Field Force Personnel to allow for
Sandoz to review the content of such RareGen Activity Materials, including with regard to the proper use of Sandoz Trademarks
and Copyrights, and provide feedback to RareGen in advance of RareGen’s reproduction and shipment of such RareGen
Activity Materials for such use. In the event of any disagreement between the Parties regarding any feedback received from
Sandoz with respect to such RareGen Activity Materials, RareGen shall not use such RareGen Activity Materials and shall
instead be limited to using other previously or subsequently accepted RareGen Activity Materials (unless Sandoz elects to
update a previously accepted RareGen Activity Material, in which case such previously approved RareGen Activity Material may
not be used), if any, and/or the Product Labeling for purposes of conducting the RareGen Activities for the Product
hereunder. RareGen covenants that it shall use only RareGen Activity Materials approved by Sandoz hereunder in the
performance of its RareGen Activities with respect to the Product under this Agreement, and such RareGen Activity Materials
shall not be modified, changed or by RareGen or any Field Force Personnel at any time without the prior written approval of
Sandoz.


 






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4.6.3       
Patient Starter Kits.


 


(a)              
RareGen shall be provided by Sandoz, and Sandoz (or its designee) shall direct ship to designated specialty pharmacies (for
distribution to physicians and other health care providers as agreed upon by the JSC and consistent with the RareGen Activity Plan
and Budget), the quantity of Patient Starter Kits that the JSC determines is required for RareGen to adequately engage in the patient
onboarding activities hereunder consistent with the RareGen Activity Plan and Budget. In order to assist Sandoz in the planning
of Patient Starter Kits production runs, RareGen will, promptly following the Effective Date, provide Sandoz with a twelve (12) month
rolling forecast for Patient Starter Kit requirements; provided however, the such forecast shall not be deemed a supply or delivery
obligation of Sandoz, except as expressly approved by the JSC. Such forecast shall be updated each month and delivered together
with the Forecast. The quantity of Patient Starter Kits supplied by Sandoz pursuant to this Section 4.6.3(a) shall be included
in the total quantity of Product supplied by Sandoz pursuant to Section 2.7, and, for clarity, Sandoz shall not be required
and is under no obligation to supply the Product (including any quantity of Patient Starter Kits) in any one Calendar Year in excess
of the Annual Maximum Quantity.


 


(b)              
RareGen shall comply with Sandoz’s standard operating procedures regarding Patient Starter Kits, as provided in writing
by Sandoz and as reasonably adjusted in good faith by Sandoz from time to time, as communicated by Sandoz to RareGen in writing.
Sandoz shall provide copies of all such policies in effect as of the Effective Date to RareGen, and any reasonable good faith modifications
thereto shall be delivered to RareGen promptly. Annually, the principal executive officer or chief compliance officer of RareGen
shall submit to Sandoz a certificate of compliance with Sandoz’s standard operating procedure regarding Patient Starter Kits.
Sandoz may, at its own expense and upon reasonable written notice to RareGen, review RareGen’s Patient Starter Kits accountability
program. Sandoz may choose to utilize the services of an outside vendor to perform this review. RareGen will be responsible for
validating the licensing status/Patient Starter Kit eligibility of Target Professionals selected to receive Patient Starter Kits
and will be responsible for maintaining an up to date status file thereafter. Sandoz shall be entitled to periodically conduct
an audit of RareGen’s license/Patient Starter Kit eligibility status file to ensure that RareGen is properly validating such
Target Professionals. RareGen will maintain records of all Patient Starter Kit shipments and quantities sent to and received by
such Target Professionals.


 


4.6.4        Ownership
of Product Materials. As between the Parties, Sandoz (or its Affiliate) shall own all right, title and interest in
and to any Product Materials (and all content contained therein) and any Product Labeling (and all content contained
therein), including applicable copyrights and trademarks, and to the extent RareGen (or any of its Affiliate’s) obtains
or otherwise has a claim to any of the foregoing, RareGen hereby assigns all of its (and its Affiliate’s) right, title
and interest in and to such Product Materials (and content) and Product Labeling (and content) to Sandoz and RareGen agrees
to execute all documents and take all actions as are reasonably requested by Sandoz to vest title to such Product Materials
(and content) and Product Labeling (and content) in Sandoz (or its designated Affiliate).


 






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4.7             
Provisions Related to Field Force Personnel.


 


4.7.1       
Activities of Field Force Personnel. RareGen hereby agrees and acknowledges that the following shall apply
with respect to itself and the Field Force Personnel:


 


(a)              
During the period beginning on the Effective Date and ending on the later to occur of (i) the expiration of the Exclusivity
Period and (ii) the last day of the twelfth (12th) full month following the Effective Date, RareGen shall ensure that the Field
Force Personnel do not conduct sales calls or other product presentations regarding products other than the Product; and thereafter
during the Term and until the first date on which there are three (3) or more generic versions of Remodulin® approved
by the FDA for sale in the Territory and commercially available in the Territory (other than the Product), RareGen shall ensure
that, with respect to any sales call or other product presentation conducted by the Field Force Personnel, the Product constitutes
the dominant product presented during such sales call or other product presentation (which may mean a sales call in which presentation
of the Product occurs first during such sales call or where the majority of time and focus is spent during such sales call on the
Product).


 


(b)              
RareGen shall instruct and cause the Field Force Personnel to use only the Product Labeling and RareGen Activity Materials
provided by RareGen and approved by Sandoz for the conduct of the RareGen Activities for the Product and consistent with Applicable
Laws. RareGen shall instruct the Field Force Personnel to, and will monitor the Field Force Personnel to ensure that such Field
Force Personnel, limit its claims of efficacy and safety for the Product (whether made orally, in writing or through any other
mechanisms) to those claims which are consistent with and do not exceed the Product Labeling and any RareGen Activity Materials.
RareGen will hire and monitor its Field Force Personnel in accordance with its customary business practices, including for compliance
with the provisions of this Agreement.


 


(c)              
RareGen shall instruct the Field Force Personnel to conduct the RareGen Activities for the Product, and will monitor the
Field Force Personnel so that such personnel conduct the RareGen Activities for the Product, in adherence in all respects with
Applicable Laws, and in a fair and balanced manner.


 


(d)              
RareGen shall comply with all Applicable Laws in the hiring, employment, and discharge of all Field Force Personnel. RareGen
represents that it is an Equal Opportunity Employer and does not discriminate against any person because of race, color, creed,
age, sex, sexual preference, marital status, or national origin.


 


(e)              
RareGen acknowledges and agrees that Sandoz does not and will not maintain or procure any worker’s compensation, healthcare,
or other insurance for or on behalf of the Field Force Personnel, all of which shall be RareGen’s sole responsibility and
in RareGen’s sole discretion.


 






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(f)                RareGen
acknowledges and agrees that all Field Force Personnel are employees or permitted subcontractors of RareGen and are not, and
are not intended to be or be treated as, employees of Sandoz or any of its Affiliates, and that such individuals are not, and
are not intended to be, eligible to participate in any benefits programs or in any “employee benefit plans” (as
such term is defined in section 3(3) of ERISA) that are sponsored by Sandoz or any of its Affiliates or that are offered
from time to time by Sandoz or its Affiliates to their own employees. All matters of compensation, benefits and other terms
of employment for any such Field Force Personnel shall be solely a matter between RareGen and such individual. Sandoz shall
not be responsible to RareGen, or to the Field Force Personnel, for any compensation, expense reimbursements or benefits
(including vacation and holiday remuneration, healthcare coverage or insurance, life insurance, severance or termination of
employment benefits, pension or profit-sharing benefits and disability benefits), payroll-related taxes or withholdings, or
any governmental charges or benefits (including unemployment and disability insurance contributions or benefits and
workmen’s compensation contributions or benefits) that may be imposed upon or be related to the performance by RareGen
or such individuals of this Agreement, all of which shall be the sole responsibility of RareGen, even if it is subsequently
determined by any Governmental Authority that any such individual may be an employee or a common law employee of Sandoz or
any of its Affiliates or is otherwise entitled to such payments and benefits.


 


(g)              
Except where a particular act or omission is expressly required by Sandoz, RareGen shall be solely responsible for its acts
and omissions and for those acts or omissions of the Field Force Personnel while performing any of the activities under this Agreement.
Except where a particular action or policy is expressly required by Sandoz, RareGen shall be solely responsible and liable for
all probationary and termination actions taken by it, as well as for the formulation, content and dissemination (including content)
of all employment policies and rules (including written probationary and termination policies) applicable to its employees and
permitted contractors.


 


4.7.2        Termination
of Employment; Cessation of RareGen Activities. If any Field Force Personnel leaves the employ of RareGen (or any of
its Affiliates), or otherwise ceases to conduct the RareGen Activities for the Product, RareGen shall, to the extent
consistent with, and in a manner similar to, its practices with respect to departures of the sales representatives, market
specialists, medical science liaisons or other field force personnel, as applicable, promoting, marketing or detailing other
products for RareGen, account for, and shall cause such departing Field Force Personnel to return to RareGen and delete from
his/her computer files (to the extent such materials or information have been provided in, or converted into, electronic
form) all materials relating to the Product that have been provided to such individual, including the RareGen Activity
Materials and account level information and training program materials, including all copies of the foregoing. RareGen shall
use reasonable efforts to cause its Field Force Personnel to execute non-competition agreements, to the extent permitted by
Applicable Laws, whereby they agree to not, directly or indirectly, with or without compensation, consult with any Person, or
conduct sales calls or other product presentations, regarding Remodulin® or any therapeutic equivalent of Remodulin®
for a period of [***] ([***]) months following termination of their employment with RareGen.


 


4.7.3        Discipline.
If Sandoz has a reasonable basis for believing any member of the Field Force Personnel has violated any Applicable Laws, or
failed to comply with this Agreement, then Sandoz shall notify RareGen of the alleged violation and RareGen shall promptly
investigate the matter and, if the allegation turns out to be true, shall take the appropriate remedial action. Subject to
the foregoing, RareGen shall be solely responsible for taking any disciplinary actions in connection with its Field Force
Personnel.


 






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4.8             
Records. RareGen shall keep accurate and complete records, consistent with pharmaceutical industry standards,
of each Detail and its obligations hereunder in connection therewith. Such records shall be kept for the longer of (i) three
(3) years after the end of the Calendar Year to which they relate and (ii) such period of time as required by Applicable Laws.


 


4.9             
Responsibility for RareGen Activity Costs and Expenses. RareGen shall be solely responsible for any and all
costs and expenses incurred by RareGen or any of its Affiliates in connection with the conduct of the RareGen Activities for the
Product hereunder, including all costs and expenses in connection with Sales Representatives, including salaries, travel expenses
and other expenses, credentialing, licensing, providing benefits, deducting federal, state and local payroll taxes, and paying
workers’ compensation premiums, unemployment insurance contributions and any other payments required by Applicable Laws to
be made on behalf of employees.


 


4.10         
Managed Care Activities. With respect to the Product in the Field in the Territory, RareGen shall, at its
cost and expense, manage and carry out efforts related to obtaining reimbursement for the Product in the Territory and the negotiation
of arrangements with Managed Care Entities, in compliance with Applicable Laws; provided that Sandoz shall have the right to participate
in all such negotiations and discussions at its sole cost and expense; and further provided that any agreements with Managed Care
Entities regarding the Product in the Field in the Territory shall require mutual agreement of the Parties and any and all legal
expenses associated with the review and negotiation of such agreements incurred by either Party shall be at such Party’s
sole cost and expense. If the Parties are unable to mutually agree upon any such matter relating to the terms and conditions of
any such agreement, then such matter shall be finally and definitely resolved by Sandoz, except with respect to matters specifically
relating to pricing decisions relating to Managed Care Entities which shall be resolved in accordance with Section 3.5 before
action may be taken with respect thereto. Subject to the foregoing, Sandoz shall be responsible for contracting with Managed Care
Entities in the Territory.


 


ARTICLE 5

REGULATORY, SAFETY AND SURVEILLANCE, COMMERCIAL MATTERS


 


5.1             
Responsibility. As between the Parties, all regulatory matters in the Territory regarding the Product shall
be the responsibility of Sandoz, including responsibility for all communications with the FDA related to the Product, and Sandoz
shall, [***], have sole responsibility to seek and/or obtain any necessary approvals of any label, labeling,
package inserts, monographs and packaging, and the RareGen Activity Materials used in connection with the Product in the Territory,
and for determining whether the same requires approval. Sandoz agrees to use Commercially Reasonable Efforts to maintain Regulatory
Approval for the Product during the Term.


 






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5.2             
 Reporting.


 


5.2.1       
As between the Parties, Sandoz shall be responsible for any reporting of matters regarding the manufacture, sale or promotion
of the Product (including Adverse Events) to or with the FDA and other relevant regulatory authorities, in accordance with Applicable
Laws.


 


5.2.2       
Subject to the terms of this Agreement, following the Effective Date at the request of Sandoz, Sandoz and RareGen (under
the guidance of their respective quality departments, or equivalent thereof) shall execute a separate quality agreement (“Quality
Agreement”) setting forth mutually acceptable guidelines and procedures for the receipt, investigation, recordation,
communication and exchange (as between the Parties) of complaints or alleged defects with respect to the Product (which complaints
or alleged defects, in the absence of a Quality Agreement, shall be reported by RareGen through the telephonic queue number set
forth in Sandoz’s primary contact information section of the Pharmacovigilance Agreement).


 


5.3             
RareGen Involvement. RareGen shall not, without Sandoz’s prior written consent, unless so required by
Applicable Law, correspond or communicate with the FDA or with any other Governmental Authority, concerning the Product, or otherwise
take any action concerning any Regulatory Approval or other authorization under which the Product is marketed or sold. RareGen
shall provide to Sandoz, promptly upon receipt, copies of any communication from the FDA, or other Governmental Authority related
to the Product. Upon the request of Sandoz, RareGen shall provide reasonable assistance to Sandoz in connection with Sandoz’s
regulatory requirements (including Adverse Event reporting) for the Product. Subject to Applicable Laws, RareGen shall notify Sandoz
immediately upon receipt of any notice of inspection or investigation by any Governmental Authority related to any aspect of the
RareGen Activities. Sandoz shall have the right to have a representative present at any such portion of the inspection involving
any RareGen Activities. Following inspections and during any investigations by applicable Governmental Authorities, RareGen shall
do such actions or cause such actions to be done that are necessary, advisable or appropriate so that RareGen remains in good standing
with any such Governmental Authorities. Subject to Applicable Laws, RareGen shall (i) keep Sandoz fully informed of the progress
and status of any such inspection or investigation, (ii) prior to undertaking any action pursuant to this Section 5.3, notify
Sandoz of the inspection or investigation, and disclose to Sandoz, in writing, the Governmental Authorities’ assertions,
findings and related results of such inspection or investigation (the “Findings”) pertaining to the RareGen
Activities, and (iii) provide full disclosure to Sandoz with respect to any action undertaken or proposed to be undertaken pursuant
to this Section 5.3 prior to acting as it pertains to the RareGen Activities. In addition, if the Findings or the Governmental
Authority requests or suggests that RareGen should change any aspect of the RareGen Activities, the Parties will work together
to make any such modification, subject to Section 2.2.3; provided, however, that notwithstanding anything to the contrary
herein, RareGen will not be required to engage in any RareGen Activities that to the extent any Finding or Government Authority
has requested or suggested that RareGen may not engage in such activity.


 






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5.4              Pharmacovigilance.
Subject to the terms of this Agreement, as soon as practicable following the Effective Date (but in no event later than sixty
(60) days from the Effective Date), Sandoz and RareGen (under the guidance of their respective pharmacovigilance
departments, or equivalent thereof) shall identify and finalize the responsibilities the Parties shall employ to protect
patients and promote their well-being in a separate safety data exchange agreement (“Pharmacovigilance
Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt,
investigation, recordation, communication and exchange (as between the Parties) of safety information such as Adverse Events,
pregnancy exposure, lack of efficacy, misuse/abuse, and any other information concerning the safety of the Product. Such
guidelines and procedures will be in accordance with, and enable the Parties and their Affiliates to fulfill, local and
international regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be
consistent with relevant FDA and International Council for Harmonization (ICH) guidelines, except where said guidelines may
conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall
prevail. The Pharmacovigilance Agreement shall provide that: (i) Sandoz shall be responsible for all pharmacovigilance
activities regarding the Product, including signal detection, medical surveillance, risk management, global medical
literature review and monitoring, Adverse Event reporting and responses to regulatory authority requests or enquiries, and
shall provide information related thereto to RareGen, and (ii) in the event RareGen receives safety information regarding the
Product, or information regarding any safety-related regulatory request or inquiry, RareGen shall notify Sandoz as soon as
practicable, but, in any event, within the timelines set forth in the Pharmacovigilance Agreement.


 


5.5             
Unsolicited Requests for Medical Information. RareGen shall direct to Sandoz any unsolicited requests for
off-label medical information from health care professionals with respect to the Product promptly following receipt by RareGen
(but in no event later than two (2) business days after receipt). Sandoz shall, within two (2) business days following
receipt of any such request from RareGen, either elect to address any such requests directly or provide approved responses relating
to the Product to RareGen for use in addressing these information requests, which responses must be used by RareGen in responding
to such requests, subject to approval of such responses by RareGen. RareGen will not alter these responses without the prior written
approval of Sandoz (in its sole discretion).


 


5.6             
Recalls and Market Withdrawals. As between the Parties, Sandoz shall have the sole right to determine whether
to implement a recall, field alert, withdrawal or other corrective action related to the Product. Subject to this Section 5.6,
Sandoz shall bear the cost and expense of any recall, field alert, withdrawal or other corrective action except to the extent such
recall, field alert, withdrawal or other corrective action arises out of RareGen’s breach under this Agreement. RareGen shall
have no right to determine or implement any of the foregoing with respect to the Product. In the event that RareGen incurs any
reasonably and properly incurred cost related to any recall, field alert, withdrawal or other corrective action related to the
Product (except to the extent such recall, field alert, withdrawal or corrective action arises out of RareGen’s breach under
this Agreement), then Sandoz shall reimburse RareGen for all such costs.


 


5.7              Reporting
Responsibilities. Notwithstanding the foregoing provisions of this ARTICLE 5, each Party shall be responsible for its
own reporting requirements in the Territory arising from conducting Details pursuant to Applicable Law. RareGen shall provide
to Sandoz, in a format reasonably acceptable to Sandoz, the data and other information called for on the spreadsheet
previously provided to RareGen in an email sent on July 26, 2018 at 9:22am with subject line “Sunshine Act
Reporting”, on a timely basis (i.e., in the case of manual reporting of such data and other information, within fifteen
(15) days following the end of each Calendar Quarter, and, in the case of automated reporting of such data and other
information, on a periodic basis during each Calendar Quarter as reasonably requested by Sandoz) for Sandoz’s reporting
under the Physician Payments Sunshine Act and other Applicable Laws. In connection therewith, RareGen will (i) cooperate
with Sandoz to receive training from Sandoz on manual or automated reporting of such data and other information and the use
of such spreadsheet, as applicable, and (ii) assist Sandoz in the proper identification of any Person included in the
reporting of such data and other information.


 






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5.8             
Booking of Sales Revenues. As between the Parties, the following shall apply: Sandoz shall retain ownership
of the rights to the Product and record on its books all revenues from sales of the Product. Sandoz shall be exclusively responsible
for accepting and filling purchase orders, billing, and returns with respect to the Product. If RareGen receives an order for the
Product, it shall promptly transmit such order to Sandoz (or its designee) for acceptance or rejection. Sandoz shall have sole
responsibility for shipping, distribution and warehousing of Product, and for the invoicing and billing of purchasers of the Product
and for the collection of receivables resulting from the sales of the Product in the Territory.


 


5.9             
Returns. RareGen is not authorized to accept any Product returns. RareGen shall advise any customer who attempts
to return any Product to RareGen (or its Affiliates) that such Product must be shipped by the customer to the facility designated
by Sandoz from time to time in writing (and in accordance with other written instructions provided by Sandoz). Sandoz shall provide
RareGen with written instructions as to how RareGen should handle any Product that is physically returned to RareGen. RareGen shall
take no other actions with respect to such return without the prior written consent of Sandoz.


 


ARTICLE 6

FINANCIAL PROVISIONS


 


6.1             
Initial Milestone Payment. On the Effective Date, RareGen shall pay to Sandoz a non-refundable, non-creditable
milestone payment of ten million Dollars ($10,000,000) in partial consideration for the right to conduct RareGen Activities for
the Product and receive a portion of Net Profits granted under this Agreement.


 


6.2             
Quality Release Milestone Payment. RareGen shall pay Sandoz a non-refundable, non-creditable milestone payment
of ten million Dollars ($10,000,000) upon the successful quality release by Sandoz of nine thousand (9,000) units of Product (such
units of Product, the “Quality Release Milestone Units”) in partial consideration for the right to conduct RareGen
Activities for the Product and receive a portion of Net Profits under this Agreement (such event, the “Quality Release
Milestone”). Sandoz shall provide to RareGen notice of its achievement of the Quality Release Milestone together with
the Certificates of Analysis with respect to the Quality Release Milestone Units (the delivery of which shall constitute sufficient
evidence of Sandoz’s achievement of the Quality Release Milestone), and RareGen shall pay such amount within fifteen (15) days
after receipt thereof.


 


6.3              Profit
Sharing. The terms and conditions of this Section 6.3 shall govern each Party’s rights and obligations
with respect to Net Profits during the Term: (i) for that portion of aggregate Net Profits in the Territory during the
Term less than or equal to [***] Dollars ($[***]), Sandoz shall receive [***] percent ([***]%) of all such
Net Profits, and RareGen shall receive [***] percent ([***]%) of all such Net Profits; (ii) for that portion of aggregate Net
Profits in the Territory during the Term greater than [***] Dollars ($[***]) but less than or equal to five
hundred million Dollars ($500,000,000), Sandoz shall receive [***] percent ([***]%) of all such Net Profits, and RareGen shall
receive [***] percent ([***]%) of all such Net Profits; and (iii) for that portion of aggregate Net Profits in the Territory
during the Term greater than five hundred million Dollars ($500,000,000), Sandoz shall receive twenty-five percent (25%) of
all such Net Profits, and RareGen shall receive seventy-five percent (75%) of all such Net Profits. For clarity, the tiers
set forth in this Section 6.3 shall be with respect to the aggregate of all Net Profits in the Territory during the
Term.


 






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6.4              Acceleration
Payment. Subject to Section 13.2 and RareGen not being in material breach of its obligations under this
Agreement (where such breach is not cured (if able to be cured) within [***] ([***]) days following RareGen’s receipt
of written notice of such breach), in the event of an FTS Event, Sandoz will pay RareGen the applicable Acceleration Payment
within [***] ([***]) days after the end of such Calendar Quarter. Any Acceleration Payment shall be included in
RareGen’s aggregate share of Net Profits received under this Agreement. Following December 31, 2019, Sandoz shall
have the right to credit against any payments owed to RareGen under Section 6.3 the aggregate amount of all Acceleration
Payments paid to RareGen under this Agreement.


 


6.5             
Accounting Standards. All costs and expenses and other financial determinations with respect to this Agreement
shall be determined in accordance with IFRS, on a consistent basis.


 


6.6             
Reports; Payments; Cumulative Calculation.


 


6.6.1        Quarterly
Reports and Payments. Within [***] ([***]) days after the end of each Calendar Quarter during the Term, Sandoz
shall provide to RareGen a written report setting forth in reasonable detail the calculation of Net Profit, Net Sales, and
gross-to-net sales in the Territory for such Calendar Quarter, and amounts owed by Sandoz to RareGen, as necessary to
accomplish the sharing of Net Profit in the Territory in accordance with Section 6.3 for the applicable Calendar
Quarter, and such payment shall be made together with such report.


 


6.6.2        Reconciliation.
At the end of each Calendar Year, a final reconciliation shall be conducted by comparing the share of Net Profit to which a
Party is otherwise entitled for such Calendar Year pursuant to Section 6.3 against the sum of all amounts previously
paid or retained by such Party for prior Calendar Quarters during such Calendar Year, and the Parties shall make reconciling
payments to one another no later than [***] ([***]) days after the end of such Calendar Year, if and as necessary to ensure
that each Party receives for such Calendar Year its share of Net Profits in accordance with Section 6.3.


 


6.7             
Taxes.


 


6.7.1       
Cooperation and Coordination. The Parties acknowledge and agree that it is their mutual objective and intent
to minimize, to the extent feasible and in compliance with Applicable Laws, taxes payable with respect to their activities under
this Agreement and that they shall use reasonable efforts to cooperate and coordinate with each other to achieve such objective.


 






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6.7.2       
 Taxes on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share
of income arising directly or indirectly from the efforts of the Parties under this Agreement.


 


6.7.3       
Payment of Tax. To the extent Sandoz is required to deduct and withhold taxes from any payment to RareGen,
Sandoz shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to RareGen
an official tax receipt or other evidence of timely payment sufficient to enable RareGen to claim the payment of such taxes as
a deduction or tax credit. RareGen shall provide Sandoz any tax forms that may be reasonably necessary in order for Sandoz to not
withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty and Sandoz shall apply the reduced
rate of withholding, or dispense with withholding, as the case may be. Each Party shall provide the other with reasonable assistance
to enable the recovery, as permitted by Applicable Laws, of withholding taxes, value added taxes, and similar obligations resulting
from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or value
added tax.


 


ARTICLE 7

AUDIT RIGHTS


 


7.1              RareGen.
RareGen shall have the right, upon reasonable written notice during the Term, through an independent, internationally
recognized, certified public accounting firm selected by RareGen and reasonably acceptable to Sandoz and upon execution of a
confidentiality agreement reasonably satisfactory to Sandoz in form and substance, to inspect and audit the records and books
of account maintained by Sandoz, or any Affiliate, as applicable, with respect to Net Sales (including all gross-to-net
deductions), Net Profits, Product write-offs, and COGS of the Product in order to confirm the accuracy and completeness of
such records and books of account and all payments hereunder during regular business hours; provided, however, that
(i) such examination shall not take place more often than once per every twelve (12) months, (ii) such
examination shall not cover a period of time that has previously been audited, and (iii) such accountant shall report to
RareGen only as to the accuracy and completeness of the reports or payments provided or made by Sandoz under this Agreement.
Sandoz shall reasonably cooperate in any such inspection or audit conducted by an accounting firm on behalf of RareGen. Any
adjustments required as a result of overpayments or underpayments identified through the exercise of audit rights shall be
made by subtracting or adding, as appropriate, amounts from or to the next payment or, if no further payments are due, by
payment to the Party owed such adjustment within thirty (30) days after identification of such adjustment. In the event
of any adjustments required as a result of underpayments to RareGen identified through the exercise of audit rights, the full
amount of the underpayment shall be payable by Sandoz to RareGen plus interest which shall accrue and be calculated on a
daily basis at [***] percent ([***]%) per annum above the thirty (30) day US dollar LIBOR rate for the date that payment
was due, as reported by The Wall Street Journal (New York edition). Such interest shall be computed on the basis of a year of
three hundred sixty (360) days for the actual number of days such payment is delinquent. RareGen shall bear the full
out-of-pocket costs and expenses incurred in connection with any inspection or audit; provided, however, that (i) Sandoz
shall not be entitled to any payment from RareGen with respect to the use of internal resources of Sandoz and its Affiliates
(including the cost and overhead associated with the use of their employees) with respect to any such inspection or audit,
(ii) Sandoz agrees that it shall use commercially reasonable efforts to use solely internal resources in connection with any
such inspection or audit, (iii) in the event Sandoz reasonably determines that any external resources, such as any external
accounting support, is necessary in connection with any such inspection or audit, Sandoz shall notify RareGen and RareGen may
either (A) consent to the use of such external resource or (B) withdraw or modify its request to avoid
Sandoz’s need for such external resources, and (iv) Sandoz shall bear the full out-of-pocket costs and expenses of any
inspection or audit if any such inspection or audit identifies an understatement to RareGen hereunder exceeding [***] percent
([***]%) of the amounts actually payable to RareGen hereunder (provided, however, that (x) RareGen shall not be entitled to
any payment from Sandoz with respect to the use of internal resources of RareGen and its Affiliates (including the cost and
overhead associated with the use of their employees) with respect to any such inspection or audit, (y) other than the
public accounting firm used by RareGen to perform the audit pursuant to this Section 7.1, RareGen agrees that it shall
use commercially reasonable efforts to use solely internal resources in connection with any such inspection or audit).


 






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7.2             
Sandoz. During the Term, Sandoz shall, relating to Product, have the right, [***], during normal
business hours and upon reasonable prior notice, to have employees or representatives (including a public accounting firm selected
by Sandoz and reasonably acceptable to RareGen) and upon execution of a confidentiality agreement reasonably satisfactory to RareGen
in form and substance, conduct compliance inspections and audits, including reviewing books and records of RareGen related to the
activities conducted pursuant to this Agreement and interviewing Sales Representatives and other employees of RareGen, as reasonably
necessary to (i) ensure that the RareGen Activities comply with this Agreement and (ii) solely in the event RareGen terminates
this Agreement in accordance with Section 12.3.4, confirm the accuracy of the records and books of account maintained by RareGen
with respect to its operating expenses relating to the Product. RareGen shall reasonably cooperate in any such inspection or audit
conducted by any such employees or representatives of Sandoz.


 


ARTICLE 8

INTELLECTUAL PROPERTY


 


8.1             
Ownership of Intellectual Property.


 


8.1.1       
RareGen Property. Sandoz acknowledges that RareGen owns or is licensed to use certain Know-How relating to
the proprietary sales and marketing information, methods and plans that has been independently developed, discovered or licensed
by RareGen (such Know-How, the “RareGen Property”). The Parties agree that any improvement, enhancement or modification
made, discovered, conceived, reduced to practice or generated by RareGen to any RareGen Property in performing its activities pursuant
to this Agreement which is not derived from the Confidential Information of Sandoz, shall be deemed RareGen Property and shall
vest in RareGen. RareGen hereby grants to Sandoz a fully paid, royalty free, perpetual, irrevocable, worldwide, non-exclusive license
(with a right to sub-license) to any RareGen Property which is embodied or contained in Product Materials or any Intellectual Property
or Inventions assigned to Sandoz hereunder.


 






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8.1.2        Sandoz
Property. Subject to the terms of Section 8.1.1, Sandoz shall have and retain sole and exclusive right, title
and interest in and to all inventions, discoveries, writings, trade secrets, Know-How, methods, practices, procedures,
engineering information, designs, devices, improvements, manufacturing information and other technology, whether or not
patentable or copyrightable, and any patent applications, patents, or copyrights based thereon (collectively,
“Intellectual Property”) that are (i) made, discovered, conceived, reduced to practice or generated
by Sandoz (or its employees or representatives) in performing its activities pursuant to this Agreement or (ii) made
discovered, conceived, reduced to practice or generated by RareGen (or its employees or representatives) in performing its
activities pursuant to this Agreement to the extent derived from the Confidential Information of Sandoz
(“Inventions”). RareGen agrees to assign, and hereby does assign, to Sandoz (and shall cause its
Affiliates and its and their respective employees and other representatives to assign to Sandoz) any and all right, title and
interest that RareGen (or any such Affiliates, employees or other representatives) may have in or to any Invention. RareGen
shall not represent to any Third Party that it has any proprietary or property right or interest in the Product, or in any
patent relating thereto, or in any trademark or copyright used in connection therewith, other than the right to conduct the
RareGen Activities for the Product as expressly granted hereunder. For clarity, any and all Inventions and any information
contained therein or related thereto shall constitute Confidential Information of Sandoz.


 


8.2             
Title to Trademarks and Copyrights. The ownership, and all goodwill from the use, of any Sandoz Trademarks
and Copyrights shall at all times vest in and inure to the benefit of Sandoz, and RareGen shall assign, and hereby does assign,
any rights it may have in the foregoing to Sandoz.


 


8.3             
Protection of Trademarks and Copyrights. As between the Parties, Sandoz shall have the sole right (but not
the obligation), as determined by Sandoz in its sole discretion, to (i) maintain the Sandoz Trademarks and Copyrights and/or
(ii) protect and defend the Sandoz Trademarks and Copyrights. RareGen shall give notice to Sandoz of any infringement of, or challenge
to, the validity or enforceability of the Sandoz Trademarks and Copyrights promptly after learning of such infringement or challenge.
If Sandoz institutes an action against Third Party infringers or takes action to defend the Sandoz Trademarks and Copyrights, RareGen
shall reasonably cooperate with Sandoz, at Sandoz’s sole cost and expense. Any recovery obtained by Sandoz as a result of
such proceeding or other actions, whether obtained by settlement or otherwise, shall be retained by Sandoz except that Sandoz shall
pay to RareGen any reasonable out-of-pocket expenses incurred by RareGen relating to such cooperation. RareGen shall not have any
right to institute any action to defend or enforce the Sandoz Trademarks and Copyrights.


 


8.4             
Disclosure of Know-How. For clarity, the Parties hereby agree and acknowledge that to the extent that either
Party hereto has disclosed, or in the future discloses, to the other Party any Know-How or other intellectual property of such
Party or its Affiliates pursuant to this Agreement, the other Party shall not acquire any ownership rights in such Know-How or
other intellectual property by virtue of this Agreement or otherwise, and as between the Parties, all ownership rights therein
shall remain with the disclosing Party (or its Affiliate).


 






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ARTICLE 9


CONFIDENTIALITY


 


9.1             
Confidential Information.


 


9.1.1       
Confidentiality and Non-Use. Each Party agrees that, during the Term and for a period of five (5) years
thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than
as provided for in this Agreement (which includes the exercise of its rights or performance of any obligations hereunder) any Confidential
Information furnished to it by or on behalf of the other Party pursuant to this Agreement, except to the extent expressly authorized
by this Agreement or otherwise agreed in writing by the Parties. Without limiting the foregoing, each Party will use at least the
same standard of care as it uses to protect is own Confidential Information to ensure that its employees, agents, consultants and
contractors do not disclose or make any unauthorized use of such Confidential Information. Each Party will promptly notify the
other upon discovery of any unauthorized use or disclosure of the other’s Confidential Information. Any and all information
and materials disclosed by a Party pursuant to that certain Confidential Disclosure Agreement between the Parties dated November 14,
2017 (the “Confidential Disclosure Agreement”) shall be deemed Confidential Information disclosed pursuant to
this Agreement. The foregoing confidentiality and non-use obligations shall not apply to any portion of the other Party’s
Confidential Information that the receiving Party can demonstrate by competent tangible evidence:


 


(a)              
was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time
of disclosure by the other Party;


 


(b)              
was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving
Party;


 


(c)              
became generally available to the public or otherwise part of the public domain after its disclosure and other than through
any act or omission of the receiving Party, its Affiliates, sublicensees or subcontractors in breach of this Agreement;


 


(d)              
was disclosed to the receiving Party or its Affiliate by a Third Party who has a legal right to make such disclosure and
who did not obtain such information directly or indirectly from the other Party (or its Affiliate); or


 


(e)              
was independently discovered or developed by the receiving Party or its Affiliate without access to or aid, application,
use of the other Party’s Confidential Information, as evidenced by a contemporaneous writing.


 


9.1.2       
Authorized Disclosure. Notwithstanding the obligations set forth in Section 9.1.1, a Party may disclose
the other Party’s Confidential Information and the terms of this Agreement to the extent:


 


(a)              
such disclosure is reasonably necessary (x) to comply with the requirements of Governmental Authorities; or (y) for
the prosecuting or defending litigation as contemplated by this Agreement;


 






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(b)              
 such disclosure is reasonably necessary to its Affiliates, employees, agents, consultants and contractors on a need-to-know
basis for the sole purpose of performing its obligations or exercising its rights under this Agreement; provided that in each case,
the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement
and the disclosing Party shall be liable for any failures of such disclosees to abide by such obligations of confidentiality and
non-use; or


 


(c)              
such disclosure is reasonably necessary to comply with Applicable Laws, including regulations promulgated by applicable
security exchanges, court order, administrative subpoena or order.


 


Notwithstanding the
foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to
Section 9.1.2(a) or 9.1.2(c), such Party shall promptly notify the other Party of such required disclosure and shall use reasonable
efforts to assist the other Party (at the other Party’s sole cost) in obtaining, a protective order preventing or limiting
the required disclosure.


 


9.2             
Public Announcements. No public announcement or statements (including presentations to investor meetings and
customer updates) concerning the existence of or terms of this Agreement or incorporating the marks of the other Party or their
respective Affiliates (including, as applicable, the Sandoz Trademarks and Copyrights) shall be made, either directly or indirectly,
by either Party or a Party’s Affiliates, without first obtaining the written approval of the other Party and agreement upon
the nature, text and timing of such announcement or disclosure. Either Party shall have the right to make any such public announcement
or other disclosure required by Applicable Law after such Party has provided to the other Party a copy of such announcement or
disclosure and an opportunity to comment thereon and the disclosing Party shall reasonably consider the other Party’s comments.
Each Party agrees that it shall cooperate fully with the other with respect to all disclosures regarding this Agreement to the
Securities Exchange Commission and any other Governmental Authorities, including requests for confidential treatment of proprietary
information of either Party included in any such disclosure. Once any written statement is approved for disclosure by the Parties
or information is otherwise made public in accordance with this Section 9.2, either Party may make a subsequent public disclosure
of the same contents of such statement in the same context as such statement without further approval of the other Party. Notwithstanding
anything to the contrary contained herein, in no event shall either Party disclose any financial information of the other, without
the prior written consent of such other Party, unless such financial information already has been publicly disclosed by the Party
owning the financial information or otherwise has been made part of the public domain by no breach of a Party of its obligations
under this ARTICLE 9.


 


ARTICLE 10

REPRESENTATIONS AND WARRANTIES


 


10.1         
Representations and Warranties of Sandoz. Sandoz represents and warrants to RareGen as of the Effective Date
that:


 


10.1.1   
it is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation
or formation;


 






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10.1.2   
 the execution, delivery and performance of this Agreement by it has been duly authorized by all requisite corporation action;


 


10.1.3   
it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;


 


10.1.4   
this Agreement constitutes a legal, valid and binding obligation enforceable against it in accordance with its terms subject,
as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors’
rights and to the availability of particular remedies under general equity principles;


 


10.1.5   
it is in compliance in all material respects with all Applicable Laws applicable to the subject matter of this Agreement;


 


10.1.6   
it has the right to market and sell the Product in the Territory as contemplated herein (solely subject to the rights granted
to RareGen herein), and has the right under the ANDA to one hundred and eighty (180) days of exclusivity as the sole generic product
(not including an authorized generic) and that no events have occurred that would cause such exclusivity period to terminate, expire
or be forfeited prior to the date that is six (6) months following the First Commercial Sale by Sandoz;


 


10.1.7   
it is not a party to any agreement or arrangement with any Third Party or under any obligation or restriction agreement
(including any outstanding order, judgment or decree of any court or administrative agency) which in any way limits or conflicts
with its ability to fulfill any of its obligations under this Agreement;


 


10.1.8   
neither Sandoz nor any of its personnel nor any contractors performing Manufacturing activities for the Product (i) have
been debarred under the 21 U.S.C. § 335a, (ii) are excluded, debarred, suspended, or otherwise ineligible to participate
in the Federal health care programs or in Federal procurement or nonprocurement programs, (iii) are convicted of a criminal offense
that falls within the ambit of the Federal statute providing for mandatory exclusion from participation in Federal health care
programs but has not yet been excluded, debarred, suspended, or otherwise declared ineligible to participate in those programs,
(iv) are listed on the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://oig.hhs.gov) or
(v) are listed on the General Services Administration’s List of Parties Excluded from Federal Programs (available through
the Internet at hhtp://epls.arnet.gov). If, during the Term, Sandoz or any of its personnel or any contractors or Third Parties
involved in Manufacture becomes or is the subject of a proceeding that could lead to, as applicable, (i) debarment under 21
U.S.C. § 335a, (ii) exclusion, debarment, suspension or ineligibility to participate in the Federal health care
programs or in Federal procurement or nonprocurement programs, (iii) convicted (or conviction) of a criminal offense that falls
within the ambit of the Federal statute providing for mandatory exclusion from participation in Federal healthcare programs, (iv)
listed (or listing) on the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://oig.hhs.gov)
or (v) listed (or listing) on the General Services Administration’s List of Parties Excluded from Federal Programs (available
through the Internet at hhtp://epls.arnet.gov), Sandoz shall immediately notify RareGen, and RareGen shall have the option, in
its sole discretion, to prohibit such Person from performing work relating to this Agreement or the Product;


 






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10.1.9   
 all Product delivered pursuant to the terms hereof by Sandoz or its contract manufacturer to any Third Party to whom RareGen
has conducted RareGen Activities for the Product during the Term will at shipment be in compliance with the Specifications, and
Applicable Laws, including the cGMP Requirements, and the Manufacturing of such Product will have been in accordance with the cGMP
Requirements. At the time Sandoz or its contract manufacturer makes each shipment of Product sold in connection with this Agreement,
the Product shall (i) not be adulterated or misbranded within the meaning of the Act or within the meaning of any applicable
state or municipal law in which the definitions of adulteration and misbranding are substantially the same as those contained in
the Act, as such Act and such laws are constituted and in effect at the time of delivery; (ii) not be an article that may not be
introduced into interstate commerce under the provisions of Sections 404 and 505 of the Act; and (iii) have a shelf life has
at least fifteen (15) months of the Product’s expiration remaining; and


 


10.1.10    
Sandoz has the necessary rights to Intellectual Property and technology used in connection with the Manufacture of the Product
and, to Sandoz’s knowledge, no such Intellectual Property or technology violates any intellectual property rights of any
Third Parties.


 


10.2         
Representations, Warranties and Covenants of RareGen. RareGen represents and warrants to Sandoz as of the
Effective Date that:


 


10.2.1   
it is a limited liability company duly organized and validly existing under the laws of the state or other jurisdiction
of its formation;


 


10.2.2   
the execution, delivery and performance of this Agreement by it has been duly authorized by all requisite limited liability
company action;


 


10.2.3   
it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;


 


10.2.4   
this Agreement constitutes a legal, valid and binding obligation enforceable against it in accordance with its terms subject,
as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors’
rights and to the availability of particular remedies under general equity principles;


 


10.2.5   
it is in compliance in all material respects with all Applicable Laws applicable to the subject matter of this Agreement;


 


10.2.6   
it is not a party to any agreement or arrangement with any Third Party or under any obligation or restriction agreement
(including any outstanding order, judgment or decree of any court or administrative agency) which in any way limits or conflicts
with its ability to fulfill any of its obligations under this Agreement;


 


10.2.7   
RareGen has, and shall maintain during the Term, adequate financial resources to complete its activities pursuant to this
Agreement and to otherwise perform its obligations under this Agreement;


 






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10.2.8   
 neither RareGen nor any Field Force Personnel (i) have been debarred under the 21 U.S.C. § 335a, (ii) are
excluded, debarred, suspended, or otherwise ineligible to participate in the Federal health care programs or in Federal procurement
or nonprocurement programs, (iii) are convicted of a criminal offense that falls within the ambit of the Federal statute providing
for mandatory exclusion from participation in Federal health care programs but has not yet been excluded, debarred, suspended,
or otherwise declared ineligible to participate in those programs, (iv) are listed on the HHS/OIG List of Excluded Individuals/Entities
(available through the Internet at http://oig.hhs.gov) or (v) are listed on the General Services Administration’s List
of Parties Excluded from Federal Programs (available through the Internet at hhtp://epls.arnet.gov). If, during the Term, RareGen
or any Field Force Personnel become or are the subject of a proceeding that could lead to, as applicable, (i) debarment under
21 U.S.C. § 335a, (ii) exclusion, debarment, suspension or ineligibility to participate in the Federal health care programs
or in Federal procurement or nonprocurement programs, (iii) convicted (or conviction) of a criminal offense that falls within the
ambit of the Federal statute providing for mandatory exclusion from participation in Federal healthcare programs, (iv) listed (or
listing) on the HHS/OIG List of Excluded Individuals/Entities (available through the Internet at http://oig.hhs.gov) or (v) listed
(or listing) on the General Services Administration’s List of Parties Excluded from Federal Programs (available through the
Internet at hhtp://epls.arnet.gov), RareGen shall immediately notify Sandoz, and Sandoz shall have the option, in its sole discretion,
to prohibit such Person from performing work under this Agreement. All Field Force Personnel are licensed to the extent required
and in accordance with all Applicable Laws;


 


10.2.9    it,
at all times during the Term, will have, an established compliance program designed to identify and address its own risk
areas and activities. RareGen shall: (a) with respect to its compliance program, undertake and maintain the requirements
as set forth in (x) the Novartis Supplier Code (and any published updates) which can be viewed and downloaded from
https://www.novartis.com/about-us/corporate-responsibility/resources-news/codes-policies-guidelines (and may request a copy
free of charge from Sandoz), and (y) Exhibit 10.2.9, (b) provide information and/or documentation on
reasonable request to Sandoz and its Affiliates to allow Sandoz to verify such compliance, (c) rectify identified
non-compliances with the Novartis Supplier Code and Exhibit 10.2.9 (in each case, where capable of remedy) and
report remediation progress to Sandoz on request, and (d) ensure that RareGen’s subcontractors and/or agents
participating in RareGen Activities also comply with the foregoing requirements. RareGen acknowledges and agrees that the
Novartis Supplier Code and Exhibit 10.2.9 forms an integral part of this Agreement. Failure to adhere to the
Novartis Supplier Code and/or Exhibit 10.2.9 shall entitle Sandoz to terminate this Agreement, subject to
RareGen’s right to cure in accordance with this Agreement; and


 


10.2.10   RareGen has the
necessary rights to RareGen Property and technology used in connection with the conduct of the RareGen Activities for the Product
and, to RareGen’s knowledge, no such RareGen Property or technology violates any intellectual property rights of any Third
Parties.


 


10.3          Disclaimer
of Warranty. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, SANDOZ (AND ITS AFFILIATES) AND RAREGEN
(AND ITS AFFILIATES) MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF
LAW, BY STATUTE OR OTHERWISE, AND SANDOZ (AND ITS AFFILIATES) AND RAREGEN (AND ITS AFFILIATES) EACH SPECIFICALLY DISCLAIM ANY
OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF
QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE
NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.


 






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ARTICLE 11

INDEMNIFICATION; LIMITATIONS ON LIABILITY


 


11.1         
Indemnification by Sandoz. Sandoz shall defend, indemnify and hold harmless RareGen and its Affiliates and
its and their respective officers, directors, employees, agents, representatives, successors and assigns from and against all Claims,
and all associated Losses, to the extent incurred or suffered by any of them to the extent resulting from or arising out of (a) any
misrepresentation or breach of any representations, warranties, or covenants (or any of its Affiliates or its or their respective
officers, directors, employees, agents or representatives) of Sandoz under this Agreement, (b) the negligence, willful misconduct
or violation of Applicable Laws by Sandoz (or any of its Affiliates or its or their respective officers, directors, employees,
agents or representatives), (c) the infringement of the intellectual property rights of any Third Party from the use of the
Sandoz Trademarks and Copyrights on Product Labeling or RareGen Activity Materials in accordance with this Agreement, (d) the
failure of the Product to meet Specifications, (e) the failure of Sandoz to supply Third Parties with Products in accordance
with its obligations to such Third Parties, except to the extent such failure is due to the acts or omissions of RareGen, or (f) death
or personal injury to any person related to use of the Product; except in each case to the extent any such Claims, and all associated
Losses, are caused by an item for which RareGen is obligated to indemnify Sandoz pursuant to Section 11.2.


 


11.2         
Indemnification by RareGen. RareGen shall defend, indemnify and hold harmless Sandoz and its Affiliates and
its and their respective officers, directors, employees, agents, representatives, successors and assigns from and against all Claims
and all associated Losses, to the extent incurred or suffered by any of them to the extent resulting from or arising out of (a) any
misrepresentation or breach of any representations, warranties, or covenants (or any of its Affiliates or its and their respective
officers, directors, employees, agents or representatives) of RareGen under this Agreement, (b) the negligence, willful misconduct,
or violation of Applicable Laws by RareGen (or any of its Affiliates or its and their respective officers, directors, employees,
agents or representatives), (c) the infringement of the intellectual property rights of any Third Party from the use of RareGen
Property, or (d) death or personal injury to any person related to use of the Product, arising from any breach of RareGen
under this Agreement; except in each case to the extent any such Claims, and all associated Losses, are caused by an item for which
Sandoz is obligated to indemnify RareGen pursuant to Section 11.1.


 






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11.3         
Indemnification Procedures. The Party seeking indemnification under Section 11.1 or 11.2, as applicable (the “Indemnified
Party”) shall give prompt notice to the Party against whom indemnity is sought (the “Indemnifying Party”)
of the assertion or commencement of any proceeding in respect of which indemnity may be sought under Section 11.1 or 11.2,
as applicable, and will provide the Indemnifying Party such information with respect thereto that the Indemnifying Party may reasonably
request. The failure to give such notice will relieve the Indemnifying Party of any liability hereunder only to the extent that
the Indemnifying Party has suffered actual prejudice thereby. The Indemnifying Party shall assume and control the defense and
settlement of any such action, suit or proceeding at its own expense. The Indemnified Party shall, if requested by the Indemnifying
Party, cooperate in all reasonable respects in such defense, at the Indemnifying Party’s expense. The Indemnified Party
will be entitled at its own expense to participate in such defense and to employ separate counsel for such purpose. For so long
as the Indemnifying Party is diligently defending any proceeding pursuant to this Section 11.3, the Indemnifying Party will
not be liable under Section 11.1 or 11.2, as applicable, for any settlement effected without its consent. No Party shall
enter into any compromise or settlement which commits the other Party to take, or to forbear to take, any action without the other
Party’s prior written consent (and unless such compromise or settlement includes an unconditional release of, and no admission
of liability by, the Indemnified Party from all liability in respect of such Claim).


 


11.4         
Limitation of Liability. NOTWITHSTANDING ANY OTHER PROVISION CONTAINED HEREIN (OTHER THAN AS SET FORTH IN
THE SECOND SENTENCE OF THIS SECTION 11.4), IN NO EVENT SHALL SANDOZ (OR ITS AFFILIATES) OR RAREGEN (OR ITS AFFILIATES) BE LIABLE
TO THE OTHER OR ANY OF THE OTHER PARTY’S AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY
DAMAGES (INCLUDING LOST PROFITS) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES THAT ARISE OUT OF OR RELATE TO THIS
AGREEMENT OR IN CONNECTION WITH A BREACH OR ALLEGED BREACH OF THIS AGREEMENT, WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE,
AND REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. THE FOREGOING SENTENCE SHALL NOT LIMIT (1) THE OBLIGATIONS
OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY FROM AND AGAINST THIRD PARTY CLAIMS UNDER SECTION 11.1 OR 11.2, AS APPLICABLE, OR
(2) DAMAGES AVAILABLE FOR A PARTY’S BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN ARTICLE 9.


 


11.5         
Insurance.


 


11.5.1   
Each Party acknowledges and agrees that during the Term, it shall maintain, through purchase or self-insurance, adequate
insurance, including products liability coverage and comprehensive general liability insurance, adequate to cover its obligations
under this Agreement and which are consistent with normal business practices of prudent companies similarly situated.


 


11.5.2   
Each Party shall provide written proof of the existence of such insurance to the other Party upon request. Sandoz does not
and will not maintain or procure any worker’s compensation, healthcare, or other insurance for or on behalf of any Field
Force Personnel, all of which shall be RareGen’s sole responsibility. For clarity, the insurance requirements of this Section 11.5
shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under
this ARTICLE 11.


 






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ARTICLE 12


 





TERM AND TERMINATION


 


12.1         
Term. This Agreement shall become effective as of the Effective Date and, unless earlier terminated as provided
in this ARTICLE 12, shall initially extend until the five (5) year anniversary of First Commercial Sale by Sandoz (the “Initial
Term”). After the Initial Term, this Agreement shall automatically renew for successive one (1) year terms under
the same terms of this Agreement, unless the Initial Term or any renewal period is earlier terminated as provided in this ARTICLE
12. The Initial Term, together with each such renewal period is referred to as the “Term”.


 


12.2         
Early Termination for Cause. A Party shall have the right to terminate this Agreement before the end of the
Term as follows:


 


12.2.1    by
a Party upon written notice to the other Party in the event of a material breach of this Agreement by such other Party where
such breach is not cured (if able to be cured) within [***] ([***]) days following such other Party’s receipt of
written notice of such breach (and any such termination shall become effective at the end of such [***] ([***]) day period
unless the breaching Party has cured such breach prior to the expiration of such [***] ([***]) day period);


 


12.2.2   
by either Party on [***] ([***]) days’ written notice to the other Party following the complete withdrawal of marketing
approval of the Product or of the Product itself in the Territory;


 


12.2.3   
to the extent permitted by Applicable Laws, by a Party immediately upon written notice to the other Party upon the filing
or institution of bankruptcy, reorganization, liquidation or receivership proceedings with respect to such other Party, or upon
an assignment of a substantial portion of the assets for the benefit of creditors by such other Party, or in the event a receiver
or custodian is appointed for such other Party’s business or a substantial portion of such other Party’s business is
subject to attachment or similar process; provided, however, in the case of any involuntary bankruptcy proceeding such right to
terminate shall only become effective if the party consents to the involuntary bankruptcy or such proceeding is not dismissed within [***] ([***]) days after the filing thereof;


 


12.3         
Early Termination.


 


12.3.1   
Either Party shall have the right to terminate this Agreement before the end of the Term immediately upon written notice
to the other Party if such terminating Party reasonably determines that the Product presents a threat to public health, safety
or welfare, or endangers its business reputation, so long as, in the case of a termination by Sandoz, Sandoz then ceases commercializing
the Product in the Territory.


 


12.3.2    Either
Party shall have the right to terminate this Agreement before the end of the Term immediately upon written notice to the
other Party at any time after the Initial Term in the event Sandoz is then procuring one hundred percent (100%) of its supply
of Product from a single Third Party, upon (a) expiration of the supply agreement with such Third Party in accordance
with its terms or termination by such Third Party of its obligation to supply Sandoz with respect to the Product or
termination by Sandoz of such Third Party’s obligation to supply Sandoz with respect to the Product (a
“Manufacturer Termination”); and (b) Sandoz’s failure, after exercise of Commercially
Reasonable Efforts, to secure continued supply of the Product from such Third Party and/or one or more other Third Parties
within twelve (12) months of the date of the Manufacturer Termination. The Parties acknowledge and agree that
(x) Sandoz shall promptly notify RareGen in the event it receives any notice from any such Third Party of such Third
Party’s intent to terminate its obligation to supply Sandoz with respect to the Product or in the event Sandoz provides
notice to any such Third Party of its intent to terminate such Third Party’s obligation to supply Sandoz with respect
to the Product, (y) commencing upon the date of the Manufacturer Termination and continuing until the date on which a
new source of Product supply is established (unless this Agreement is earlier terminated in accordance with this
Section 12.3.2 or as otherwise provided in this ARTICLE 12), the Parties’ obligations hereunder (other than
Sandoz’s obligations under clause (b) of this Section 12.3.2 and those obligations that would survive a
termination of this Agreement pursuant to Section 12.7) shall be suspended, and (z) Sandoz shall not have the right
to terminate this Agreement pursuant to Section 12.3.3 or 12.5 as a result of the Net Profits or profit margin for any
time period that includes such period of suspension.


 






    40


     


    

 


12.3.3   
Sandoz shall have the right to terminate this Agreement before the end of the Term on not more than ninety (90) days’
written notice after the conclusion of any full 12-month Calendar Year during the Term in the event that Net Profits in such Calendar
Year are less than or equal to ten percent (10%) of the Net Sales in such Calendar Year (a “Profit Margin Deficiency”);
provided, however, that Sandoz shall have no right to terminate this Agreement pursuant to this Section 12.3.3 (i) unless
and until aggregate amounts received by RareGen under the sharing of Net Profits in the Territory pursuant to Section 6.3
have reached thirty-two million five hundred thousand Dollars ($32,500,000), or (ii) if both (x) Net Profits or the profit
margin were adversely affected in such Calendar Year by any event or circumstance that is temporary in nature and (y) the
JSC makes a determination that the Profit Margin Deficiency is not likely to continue in the subsequent Calendar Year.


 


12.3.4   
RareGen shall have the right to terminate this Agreement before the end of the Term on not more than ninety (90) days’
written notice after the conclusion of any full twelve (12)-month Calendar Year during the Term in the event that RareGen’s
share of the Net Profits in such Calendar Year are less than or equal to RareGen’s operating expenses relating to the Product
for such Calendar Year; provided, however, that RareGen shall have no right to terminate this Agreement pursuant to this Section 12.3.4
(i) unless and until aggregate amounts received by Sandoz under the sharing of Net Profits in the Territory pursuant to Section 6.3
have reached twenty-eight million one hundred twenty-five thousand Dollars ($28,125,000), or (ii) if both (x) Net Profits
or its operating expenses relating to the Product were adversely affected in such Calendar Year by any event or circumstance that
is temporary in nature and (y) the JSC makes a determination that RareGen’s share of the Net Profits is not likely to
continue to be less than its operating expenses relating to the Product in the subsequent Calendar Year.


 


12.4          Termination
Due to Change of Control. In the event of a Change of Control of RareGen during the Term, RareGen (or its successor)
shall deliver a written notice of such Change of Control to Sandoz within [***] ([***]) days of the closing date of such
Change of Control. RareGen (or its successor) shall issue, within [***] ([***]) days of Sandoz’s written request
after the closing date of such Change of Control, a letter to certify (a) its agreement to comply with the obligations
of RareGen under this Agreement, and (b) its financial condition is sufficient to complete its activities pursuant to
this Agreement and to otherwise perform its obligations under this Agreement. In the event that either (i) RareGen (or
its successor) is unable to certify (a) or (b) above, (ii) the Change of Control of RareGen involves a Competitor,
or (iii) the Change of Control of RareGen involves a Third Party who is engaged in any activity that, if conducted by
RareGen, would be a breach of Section 2.4.1, then Sandoz shall have the right to terminate this Agreement upon [***]
([***]) days’ written notice to RareGen (or its successor).


 






    41


     


    

 


12.5         
Termination Due to Failure to Achieve Minimum Net Profits. RareGen, subject to RareGen’s compliance
with the terms and conditions of this Agreement, and Sandoz shall each have the right to terminate this Agreement on not more than
ninety (90) days’ written notice after the conclusion of the Initial Term or any applicable renewal period in the event
that Net Profits in the last Calendar Year of the Initial Term or such renewal period, as applicable, are less than five million
Dollars ($5,000,000) (and any such termination shall become effective at the end of such ninety (90) day period).


 


12.6         
Effects of Termination.


 


12.6.1   
Subject to Section 12.6.2, upon the expiration or effective date of termination of this Agreement, (i) Sandoz
shall pay any remaining amounts due pursuant to Section 6.3 relating to all periods prior to the effective date of such expiration
or termination, (ii) all rights and obligations of both Parties hereunder shall immediately terminate, subject to any survival
as set forth in Section 12.7, (iii) RareGen, at Sandoz’s direction, shall immediately return to Sandoz or destroy in
accordance with all Applicable Laws all Product Materials, reports and other tangible items provided by or on behalf of Sandoz
to RareGen or otherwise developed or obtained by RareGen pursuant to the terms of this Agreement (other than RareGen Property)
(and at the request of Sandoz, RareGen shall certify destruction of such materials if RareGen does not to return such materials
to Sandoz), (iv) RareGen shall immediately cease all RareGen Activities with respect to the Product, (iv) neither Sandoz nor RareGen
shall have any obligation with respect to any Firm Zone or Forecasts, and (v) each of RareGen and Sandoz shall, at the other
Party’s direction, either return to such other Party or destroy all Confidential Information of such other Party (provided
that each Party may retain one copy of the other Party’s Confidential Information solely for archival purposes).


 


12.6.2    Upon
termination of this Agreement by Sandoz pursuant to Section 12.3.3 or 12.5, RareGen may elect to continue
commercialization of the Product in the Field in the Territory by providing Sandoz written notice of such intention within
[***] ([***]) days of receipt of Sandoz’s notice of termination. In such event, (i) the Parties shall
negotiate in good faith the terms and conditions of an agreement pursuant to which Sandoz will transfer the rights to the
ANDA for the Product to RareGen for a purchase price in accordance with the then-prevailing fair market value of the Product,
and (ii) Sandoz shall use Commercially Reasonable Efforts to facilitate RareGen’s entering into a direct supply
agreement with Sandoz’s Third Party manufacturing provider of the Product.


 


12.7         
Survival. Termination or expiration of this Agreement shall be without prejudice to any rights that shall
have accrued to the benefit of any Party prior to such termination or expiration. Notwithstanding any expiration or termination
of this Agreement, such expiration or termination shall not relieve any Party from obligations which are expressly or by implication
intended to survive expiration or termination, including Sections 2.4.2, 4.6.4, 4.7.2, 4.8, 5.7, 5.9, 6.7, 11.1, 11.2, 11.3,
11.4, 12.6 and 12.7, and Articles 7, 8, 9 and 13 (to the extent applicable to implementation of the survival of the preceding Sections
and Articles), which shall survive and be in full force and effect.


 






    42


     


    

 


ARTICLE 13

MISCELLANEOUS


 


13.1         
Use of Affiliates. RareGen shall not have the right to engage or utilize any Affiliate to fulfill its obligations
under this Agreement nor shall it subcontract any of its obligations under this Agreement to any Affiliate, except in accordance
with the provisions of Section 2.6. For clarity, Sandoz shall have the right to exercise its rights and perform its obligations
under this Agreement either itself or through any of its Affiliates; provided that Sandoz shall remain responsible for the performance
of any such Affiliates with all terms of this Agreement. In addition, in each case where a Party’s Affiliate has an obligation
pursuant to this Agreement or performs an obligation pursuant to this Agreement, such Party shall cause and compel such Affiliate
to perform such obligation and comply with the terms of this Agreement.


 


13.2         
Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under
or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or
delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including, embargoes,
war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil commotions, strikes, lockouts
or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any Governmental Authority.
For the avoidance of doubt, the failure (for reasons other than force majeure) of any Third Party engaged by a Party to perform
all or any portion of such Party’s obligations under this Agreement shall not be a force majeure under this Agreement. The
affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practicable, and shall promptly
undertake all reasonable efforts necessary to cure such force majeure circumstances and re-commence its performance hereunder as
soon as practicable.


 


13.3          Assignment;
Change of Control. Except as provided in this Section 13.3, this Agreement may not be assigned or otherwise
transferred, nor may any rights or obligations hereunder be assigned or transferred, by either Party, whether by contract or
operation of law, whether in a merger, sale of stock, sale of assets or other transaction, without the written consent of the
other Party (such consent not to be unreasonably withheld). In the event either Party desires to make such an assignment or
other transfer of this Agreement or any rights or obligations hereunder, such Party shall deliver a written notice to the
other Party requesting the other Party’s written consent in accordance with this Section 13.3, and the other Party
shall provide such Party written notice of its determination whether to provide such written consent within thirty
(30) days following its receipt of such written notice from such Party. Notwithstanding the foregoing, Sandoz may,
without RareGen’s consent, assign this Agreement and its rights and obligations hereunder in whole or in part to
(a) a Sandoz Affiliate or (b) a Third Party in connection with a Change of Control of Sandoz; provided that such
assignee shall remain subject to all of the terms and conditions hereof in all respects and shall assume, in all respects,
all obligations of Sandoz hereunder whether accruing before or after such assignment. Any permitted assignee shall assume all
assigned obligations of its assignor under this Agreement. Any attempted assignment not in accordance with this
Section 13.3 shall be void. This Agreement shall be binding on, and inure to the benefit of, each Party, and its
permitted successors and assigns.


 






    43


     


    

 


13.4         
Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or
unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not
in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive
rights of the Parties. The Parties shall in such an instance use reasonable efforts to replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.


 


13.5         
Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered
personally, sent by e-mail (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent
by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested,
addressed as follows:


 


	if to RareGen, to:	RareGen, LLC
	 	c/o PBM Capital Group, LLC
	 	200 Garrett Street, Suite S
	 	Charlottesville, Virginia 22902
	 	Attn: Corporate Counsel
	 	 
	if to Sandoz, to:	Sandoz Inc.
	 	100 College Road West
	 	Princeton, New Jersey 08540
	 	Attention: President
	 	 
	And	Sandoz Inc.
	 	100 College Road West
	 	Princeton, New Jersey 08540
	 	Attention: General Counsel






 


or to such other address(es)
as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice
shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a business day (or
if delivered or sent on a non-business day, then on the next business day); (b) on the business day after dispatch if sent
by nationally-recognized overnight courier; or (c) on the fifth (5th) business day following the date of mailing, if sent
by mail.


 


13.6          Governing
Law. This Agreement and any and all matters arising directly or indirectly herefrom shall be governed by and
construed and enforced in accordance with the internal laws of the State of New York, U.S.A. applicable to agreements made
and to be performed entirely in such state, without giving effect to the conflict of law principles thereof. The Parties
expressly agree that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this
Agreement or any Party’s performance hereunder.


 






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13.7         
Dispute Resolution.


 


13.7.1   
JSC Jurisdiction; Escalation for Other Disputes. Except for disputes resolved by the procedures set forth
in Section 3.5.1, if a dispute arises between the Parties in connection with or relating to this Agreement or any document
or instrument delivered in connection herewith (a “Dispute”), then either Party shall have the right to refer
such dispute to the Senior Officers who shall confer within ten (10) days after such Dispute was first referred to them to
attempt to resolve the Dispute by good faith negotiations. Any final decision mutually agreed to by the Senior Officers in writing
shall be conclusive and binding on the Parties. If such Senior Officers do not agree on the resolution of an issue within thirty
(30) days after such issue was first referred to them, either Party may, by written notice to the other Party, initiate arbitration
for resolution of such Dispute pursuant to Section 13.7.2.


 


13.7.2   
Arbitration of Other Disputes. If a Dispute is not resolved by the Senior Officers pursuant to Section 13.7.1,
such Dispute shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators
appointed in accordance with such rules. The legal place of arbitration shall be New York, New York. The language of the arbitration
shall be English.


 


13.8         
Waiver of Jury Trial. EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN
ANY LEGAL PROCEEDING ARISING OUT OF OR RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.


 


13.9         
Entire Agreement; Amendments. This Agreement, together with the Schedules and Exhibits hereto, contains the
entire understanding of the Parties with respect to the subject matter hereof. Any other express or implied agreements and understandings,
negotiations, writings and commitments, either oral or written, in respect to the subject matter hereof (including the Confidential
Disclosure Agreement, but solely with respect to information which is deemed Confidential Information hereunder) are superseded
by the terms of this Agreement. The Schedules and Exhibits to this Agreement are incorporated herein by reference and shall be
deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly
executed by authorized representative(s) of both Parties hereto.


 


13.10     
Headings. The captions to the several Articles, Sections and subsections hereof are not a part of this Agreement,
but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.


 


13.11     
Independent Contractors. It is expressly agreed that RareGen and Sandoz shall be independent contractors and
that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither RareGen nor
Sandoz shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which
shall be binding on the other Party, without the prior written consent of the other Party.


 






    45


     


    

 





13.12     
 Third Party Beneficiaries. No Person other than Sandoz or RareGen (and their respective Affiliates and permitted
successors and assignees hereunder) shall be deemed an intended beneficiary hereunder or have any right to enforce any obligation
of this Agreement.


 


13.13     
Waiver. The waiver by either Party hereto of any right hereunder, or of any failure of the other Party to
perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach
by or failure of such other Party whether of a similar nature or otherwise.


 


13.14     
Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be
cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.


 


13.15     
Waiver of Rule of Construction. Each Party has had the opportunity to consult with counsel in connection with
the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement
shall be construed against the drafting Party shall not apply.


 


13.16     
Use of Names. Except as otherwise provided herein, neither Party shall have any right, express or implied,
to use in any manner the name or other designation of the other Party or any other trade name, trademark or logo of the other Party
for any purpose in connection with the performance of this Agreement.


 


13.17     
Further Actions and Documents. Each Party agrees to execute, acknowledge and deliver all such further instruments,
and to do all such further acts, as may be reasonably necessary or appropriate to carry out the intent and purposes of this Agreement.


 


13.18     
Certain Conventions. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause,
Schedule or Exhibit shall be deemed to be a reference to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit,
of or to, as the case may be, this Agreement, unless otherwise indicated. Unless the context of this Agreement otherwise requires,
(a) words of any gender include each other gender, (b) words such as “herein”, “hereof”, and
“hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear,
(c) words using the singular shall include the plural, and vice versa, (d) whenever any provision of this Agreement uses
the term “including” (or “includes”), such term shall be deemed to mean “including without limitation”
(or “includes without limitations”), and (e) references to any Articles or Sections include Sections and subsections
that are part of the references’ Article or Section (e.g., a section numbered “Section 2.2.1” would be part
of “Section 2.2”, and references to “Article 2” or “Section 2.2” would refer
to material contained in the subsection described as “Section 2.2.1”).


 


13.19     
Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an
original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile signatures,
which signatures shall have the same force and effect as original signatures.


 


[Signature page follows.]


 









    46


     


    

 


IN WITNESS WHEREOF,
the Parties have executed this Agreement as of the Effective Date.


 


	 	SANDOZ INC.
	 	 
	 	By:   	/s/ Carol Lynch
	 	Name: Carol Lynch
	 	Title: President Sandoz Inc.    
	 	 
	 	RAREGEN, LLC    
	 	 
	 	By:	 /s/ Paul B. Manning
	 	Name: Paul B. Manning
	 	Title: Director





 


[Signature Page
to Promotion Agreement]


 









    47


     


    

 


Exhibit 1.19



Competitors


 






    1


     


    

 





Exhibit 1.51



Minimum Order Quantity


 






    2


     


    

 





Exhibit 1.53



Example Calculations of Net Sales




 






    3


     


    

 





Exhibit 1.71



Examples of RareGen Activities other than Detailing


 









    4


     


    

 


Exhibit 2.7.2



Annual Maximum Quantity


 






    5


     


    

 





Exhibit 4.2.2



Initial RareGen Activity Plan and Budget


 






    6


     


    

 





Exhibit 10.2.9



Sandoz Compliance Program Requirements


 








    7