XML 41 R28.htm IDEA: XBRL DOCUMENT v3.24.1.u1
Related Party Transactions
 3 Months Ended
Mar. 31, 2024
Related Party Transactions [Abstract]  
Related Party Transactions Related Party Transactions
The Company has various business agreements with certain parties in which there is some common ownership. However, the Company does not directly own or manage any of such related parties. Except as disclosed below, as of and for the three months ended March 31, 2024, there were no material changes to our related party agreements or relationships as described in Note 24. Related Party Transactions and Note 22. Stockholders’ Equity in our 2023 Annual Report on Form 10-K.
The following table summarizes the Company’s related party transactions (in thousands):
Three Months Ended March 31,
Related Party and Nature of TransactionCaption in Balance Sheet and Statement of Operations20242023
Kashiv Biosciences LLC
Parking space leaseResearch and development$25 $17 
Development and commercialization agreement - Ganirelix Acetate and Cetrorelix AcetateResearch and development$— $50 
Development and commercialization agreement - Filgrastim and Pegfilgrastim - Royalty expense (Releuko and Fylnetra)Cost of goods sold$4,526 $144 
Storage agreementResearch and development$(77)$(48)
Inventory purchases under development and commercialization agreement - Filgrastim and Pegfilgrastim (Releuko and Fylnetra)Inventory and cost of goods sold$1,216 $— 
Generic development supply agreement - research and development materialResearch and development$(48)$— 
Generic development supply agreement - development activity deferred incomeDeferred revenue and net revenue$(422)$— 
Development and commercialization agreement - Long-acting injectableResearch and development$500 $— 
Other Related Parties
Kanan, LLC - operating leaseInventory and cost of goods sold$592 $566 
Sutaria Family Realty, LLC - operating leaseInventory and cost of goods sold$314 $305 
Apace KY, LLC d/b/a Apace Packaging LLC - packaging agreementInventory and cost of goods sold$5,001 $1,836 
Tracy Properties LLC - operating leaseSelling, general and administrative$143 $169 
AzaTech Pharma LLC - supply agreementInventory and cost of goods sold$2,312 $575 
AvPROP, LLC - operating leaseSelling, general and administrative$44 $47 
Avtar Investments, LLC - consulting servicesResearch and development$69 $188 
AlkermesInventory and cost of goods sold$12 $2 
R&S Solutions - logistics servicesSelling, general and administrative$— $20 
Members - tax receivable agreement (TRA liability)Other expense$1,948 $826 
The following table summarizes the amounts due to or from the Company for related party transactions (in thousands):
March 31, 2024December 31, 2023
Kashiv - various agreements$1,434 $954 
Apace Packaging, LLC - packaging agreement9 — 
Alkermes— 1 
AzaTech Pharma LLC78 — 
Related party receivables - short term $1,521 $955 
Kashiv - various agreements$5,773 $3,179 
Apace Packaging, LLC - packaging agreement1,863 1,091 
AzaTech Pharma LLC - supply agreement1,650 1,958 
Avtar Investments LLC - consulting services22 100 
Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes
442 442 
Members - tax receivable agreement3,532 549 
Rondo Class B unit holders - tax distributions3,777 — 
Alkermes Plc16 2 
Related party payables - short term $17,075 $7,321 
Kashiv - contingent consideration
$530 $430 
Sellers of AvKARE LLC and R&S - accrued interest on Sellers Notes
8,691 8,139 
Members - tax receivable agreement2,173 3,207 
Related party payables - long term $11,394 $11,776 
Kashiv Biosciences
Amendment to Biosimilar License Agreement
In March 2024, the Company amended the Kashiv Biosimilar Agreement (as defined in Note 24. Related Party Transactions in the Company’s 2023 Annual Report on Form 10-K) to include two additional in-development products, a pre-filled auto-injector delivery system for peg-filgrastim and a pre-filled on-body injector (OBI) delivery system for peg-filgrastim. Consistent with the existing terms, Kashiv is responsible for development, regulatory filings, obtaining FDA approval, and manufacturing, and Amneal is responsible for marketing, selling, and pricing activities of these product candidates. The amendment did not change the contractual terms related to existing commercialized biosimilar products.
The amendment provides an incremental $14.5 million in potential future milestone payments specific to these in-development products, including $7.0 million for clinical and developmental milestones and $7.5 million for regulatory approval and first commercial-sales milestones. In addition, the amendment clarifies that future net sales milestones payments of up to $37.5 million, which did not change, shall be contingent upon reaching certain commercial sales volume objectives for the aggregate of all products under the amended agreement. The agreement provides for Amneal to pay a profit share equal to 50% of net profits, after considering manufacturing and marketing costs.
No amounts were paid or recognized during the three months ended March 31, 2024 pursuant to this amendment.

Long-Acting Injectable License and Supply Agreement
In December 2022, Amneal and Kashiv entered into a development supply agreement specific to four generic product candidates. Amneal is responsible for manufacturing batch products and performing certain developmental activities on behalf of Kashiv. Kashiv, as owner of the IP, is responsible for regulatory filings, obtaining FDA approval, marketing, selling, and pricing activities. Pursuant to the terms of the development supply agreement, Amneal is eligible to earn up to $2.4 million related to the aforementioned services.

Pursuant to the development supply agreement, Amneal maintained a right of first offer and negotiation to the licensing of each generic product candidate. In March 2024, Amneal and Kashiv entered into a license and supply agreement for the development and commercialization of a long-acting injectable (the “Injectable License and Supply Agreement"). The existing development supply agreement remains effective for the remaining three generic product candidates.
Subject to the terms of the Injectable License and Supply Agreement, Amneal is responsible for development, regulatory approval, and commercialization of the product candidate in the U.S., whereas Kashiv is responsible for development and regulatory approval of the product candidate for all other territories outside the U.S. Contingent upon Kashiv obtaining regulatory approval outside the U.S., Amneal shall manufacture the commercial supply for Kashiv at a stated price. The term of the agreement is 10 years from the respective product’s launch date in the U.S.

During the three months ended March 31, 2024, the Company recorded R&D expense for a $0.5 million payment made upon execution of the license and supply agreement. The agreement provides for potential future milestone payments to Kashiv of up to $35.0 million as follows: (i) up to $10.0 million relating to developmental milestones; (ii) up to $20.0 million for U.S. regulatory approval and initial commercial launch milestones; and (iii) up to $5.0 million for the achievement of annual commercial milestones. In addition, the agreement provides for Amneal to pay a profit share equal to 50% of net profits, after considering manufacturing and marketing costs.
Refer to Note 3. Acquisitions and Note 24. Related Party Transactions in the Company’s 2023 Annual Report on Form 10-K for information on the Company’s agreements with Kashiv.