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COMMERCIALIZATION AGREEMENTS | 12 Months Ended
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Dec. 31, 2021
COMMERCIALIZATION AGREEMENTS |
COMMERCIALIZATION AGREEMENTS | NOTE 2 - COMMERCIALIZATION AGREEMENTS a. On November 30, 2009, Protalix Ltd. and Pfizer entered into the Pfizer Agreement (as amended in June 2013) pursuant to which Pfizer was granted an exclusive, worldwide license to develop and commercialize taliglucerase alfa, except for Israel and Brazil. Under the Pfizer Agreement Protalix was entitled to 40% of the results (profits or losses) earned on Pfizer’s sales of taliglucerase alfa. In October 2015, the Company entered into the Amended Pfizer Agreement with Pfizer. Pursuant to the amendment, the Company granted Pfizer an exclusive license in the entire world, including Israel but excluding Brazil. Pfizer acquired all the information, knowledge and permission to manufacture and sell Elelyso. Protalix Ltd. also agreed to provide Pfizer with:
| 1. | Manufacturing and supply of the drug substance for its incorporation into the licensed product in consideration of an agreed price per unit.
| 2. | Assistance in arranging for the manufacture of the drug substance by Pfizer or by alternative supplier chosen by Pfizer in consideration of an agreed hourly rate plus reimbursement of expenses.
Promissory note – as of the date of the amendment, the Company owed Pfizer $4.3 million as a result of the accumulated losses incurred by the Collaboration Operation. Following the new agreements, the Company committed to pay Pfizer the principal sum of the debt at the earlier of (a) November 12, 2020 and (b) the date upon which it becomes due pursuant to any event of default, as defined. In September 2020, the Company amended the outstanding $4.3 million promissory note payable to Pfizer by November 2020 to extend the maturity date to the earlier of (a) January 31, 2022 and (b) the date that the Company receives any milestone payment from Chiesi, if at all, subject to certain conditions and exceptions. The amendment also provides that the Company shall make a payment of $430,000 to Pfizer. The payment was creditable against the principal amount of the note, in whole or in part, if the Company satisfied the note in full on or prior to September 30, 2021, depending on the date the note is satisfied. As of December 31, 2020, the promissory note was classified to current liabilities. On March 29, 2021, the Company paid approximately $4.0 million to Pfizer satisfying the promissory note in full. b. In October 2017, Protalix Ltd. entered into the Chiesi Ex-U.S. Agreement with respect to the commercialization of pegunigalsidase alfa (hereafter – the drug) for the treatment of Fabry disease. Under the terms of the Chiesi Agreement, Protalix Ltd. granted to Chiesi exclusive licensing rights for the commercialization of the drug for all markets outside of the United States. At the effective date, Protalix Ltd. had maintained the exclusive commercialization rights to the drug in the United States, which rights were subsequently granted to Chiesi in July 2018. Protalix Ltd. will be mainly responsible for (i) continuing the development of the drug until a regulatory approval is granted and (ii) manufacture and supply the drug to Chiesi, based on Chiesi’s requests. The consideration consists of the following:
| 1. | Upfront, non-refundable payment of $25.0 million.
| 2. | Additional payments of up to $25.0 million in development costs, capped at $10.0 million per year.
| 3. | Payments for additional studies, as may be approved from time to time by Chiesi.
| 4. | Milestone payments of up to $320.0 million with respect to certain regulatory and commercial events as defined in the Chiesi Agreement.
| 5. | Additional payments as consideration for the supply of the drug. The payment will vary from 15% to 35% of Chiesi’s average selling price of the drug, depending on the amount of annual sales.
| 6. | Protalix Ltd. will be the sole manufacturer of the drug.
Chiesi does not have sublicensing rights (except for certain territories). In July 2018, Protalix Ltd. entered into the Chiesi U.S. Agreement with respect to the commercialization of the drug for the treatment of Fabry disease. Under the terms of the Chiesi U.S. Agreement, Protalix Ltd. granted to Chiesi exclusive licensing rights for the commercialization of the drug for all markets in the United States. Protalix Ltd. will be mainly responsible for (i) continuing the development of the drug until a regulatory approval is granted, (ii) continuing certain clinical development efforts in relation to the drug after a regulatory approval is granted and (iii) manufacture and supply the drug to Chiesi, based on Chiesi’s requests. The consideration consists of the following:
| 1. | Upfront, non-refundable payment of $25.0 million.
| 2. | Additional payments of up to $20.0 million in development costs, capped at $7.5 million per year.
| 3. | Payments for additional studies, as may be approved from time to time by Chiesi.
| 4. | Milestone payments of up to $760.0 million with respect to certain regulatory and commercial events as defined in the Chiesi Agreement, which has been reduced to $735.0 million.
| 5. | Additional payments as consideration for the supply of the drug. The payment will vary from 15% to 40% of Chiesi’s average selling price of the drug, depending on the amount of annual sales.
| 6. | Protalix will be the sole manufacturer of the drug.
Chiesi does not have sublicensing rights. As of December 31, 2021, the Company has received, or is entitled to receive, the following payments from Chiesi:
| 1. | Upfront payments equal to $50.0 million, in the aggregate.
| 2. | Payments equal to $45.0 million in consideration for development services performed.
| 3. | Payments equal to approximately $33.6 million in connection with the performance of extension studies.
| 4. | Payment equal to $10.0 million in lieu of certain milestone payments.
During 2019, 2020 and 2021, the Company recognized revenues of approximately $4.5 million, $3.5 million and $0.6 million, respectively, related to the then $10.0 million future milestone payment. The Company assessed the likelihood of achieving the milestone using the most likely amount method and evaluated for the constraint by including in the transaction price variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The $10.0 million payment was received in June 2021. c. On June 18, 2013, Protalix Ltd. entered into the Brazil Agreement with Fiocruz for BioManguinhos. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz under the Brazil Agreement, and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil. Approximately 25% of adult Gaucher patients in Brazil are currently treated with BioManguinhos alfataliglicerase. The Company is discussing with Fiocruz potential actions that Fiocruz may take to comply with its purchase obligations and, based on such discussions, the Company will determine what it believes to be the course of action that is in the best interest of the Company. d. On March 16, 2020, the Company agreed to conduct a feasibility study with Kirin Holdings Company, Limited (“Kirin”) to evaluate the production of a novel complex protein utilizing ProCellEx®, the Company’s proprietary plant cell-based protein expression system. Under the agreement, Kirin was obligated to bear the costs of conducting cell line engineering and protein expression studies on the target protein. In addition, the contract provided Kirin with an option to a future service for which the Company received a non-refundable payment in the amount of $1.0 million. During the year ended December 31, 2021, the Company completed its obligations under the agreement and the agreement expired, including the o ption to provide additional services. Following the expiration of the option, the Company recognized as revenue the $1.0 million received in March 2020.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (a) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (b) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -URI http://asc.fasb.org/topic&trid=5833765 + Details
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