Provision Language
ARTICLE 6. PURCHASE AND SUPPLY OF SUPPLIED MATERIALS
6.1 Agreement to Supply.
6.1.1 Commencing on the EFFECTIVE DATE and continuing until the COMPLETION of the TECHNOLOGY TRANSFER, PROTALIX will supply and FIOCRUZ will purchase SUPPLIED MATERIALS, in the form ( e.g., FINISHED PACKAGED PRODUCT, NAKED VIALS, BULK PRODUCT, etc.) appropriate for the then-current STAGE, that are necessary for FIOCRUZ to MANUFACTURE and/or COMMERCIALIZE the PRODUCTS in the TERRITORY for the FIELD, at the pricing set forth herein. [***]
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6.4 Price; Payment; Taxes.
6.4.1 In the event the TECHNOLOGY TRANSFER is not COMPLETED by the end of the initial seven (7) year period, FIOCRUZ shall continue to obtain from PROTALIX its requirements of PROTALIX BULK PRODUCT for production of the PRODUCT at the same terms and conditions as described above and, for the renewal periods in TERM 1, PROTALIX shall provide [***]% discount over the last price of BULK PRODUCT as described in table below (6.4.2).
6.4.2 During TERM 1, the pricing for the SUPPLIED MATERIALS shall be as follows:
ARTICLE 7. MANUFACTURE; COMMERCIALIZATION AND QUALITY CONTROL
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7.4 Quality Control Testing/Validation
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7.4.4 FIOCRUZ shall be responsible for and reimburse PROTALIX for costs and reasonably agreed upon expenses incurred to provide technical assistance or training to FIOCRUZ, including all costs and expenses relating to travel (business class tickets for all flights), local transportation, hotel, food, and reasonable per diem expenses.
7.4.5 In accordance with the payment terms in Article 9, FIOCRUZ shall pay PROTALIX for the technical assistance and training provided by PROTALIX to FIOCRUZ (as agreed upon by PROTALIX and FIOCRUZ), at the following rates:
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- Employee (other than Supervisors, Managers or Directors) [***] U.S. dollars per hour
- Supervisor: [***] U.S. dollars per hour
- Manager: [***] U.S. dollars per hour
- Senior Manager or Director [***] U.S. dollars per hour
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ARTICLE 9. ROYALTY, REPORTING AND PAYMENT TERMS
9.1 Royalties. Commencing upon FIOCRUZ’s completion of a Phase III clinical trial and obtaining a GOVERNMENTAL APPROVAL from ANVISA for the MANUFACTURE entirely by FIOCRUZ of the FINAL PRODUCT in the TERRITORY, FIOCRUZ shall pay to PROTALIX for the exploitation of the PROTALIX patent RIGHTS and the PROTALIX TECHNOLOGY in the TERRITORY a running royalty of [***] of Net Sales (the “ROYALTY PAYMENTS“), on a quarterly basis in the manner described in this Article 9. For the avoidance of doubt, (i) FIOCRUZ shall not COMMERCIALIZE the FINAL PRODUCT until completion of a Phase III clinical trial and obtaining a GOVERNMENTAL APPROVAL from ANVISA for the MANUFACTURE entirely by FIOCRUZ of the FINAL PRODUCT in the TERRITORY, and (ii) the requirement to pay ROYALTY PAYMENTS shall survive any termination or expiration of this AGREEMENT until the expiration of the last to expire PROTALIX patent in Brazil.
