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COMMERCIALIZATION AGREEMENTS | 12 Months Ended
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Dec. 31, 2023
COMMERCIALIZATION AGREEMENTS |
COMMERCIALIZATION AGREEMENTS | NOTE 2 - COMMERCIALIZATION AGREEMENTS
| a. | In October 2015, the Company entered into the Amended Pfizer Agreement with Pfizer that amended and restated the Pfizer Agreement of November 30, 2009. 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 issued to Pfizer a $4.3 million promissory representing the Company’s share of accumulated losses incurred under the Collaboration Operation. The promissory note was subsequently amended. 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, 2023, 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 $51.3 million in connection with the performance of extension studies.
| 4. | Payments equal to $30.0 million in lieu of certain milestone payments.
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.

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