Provision Language
ARTICLE 7. MANUFACTURE; COMMERCIALIZATION AND QUALITY CONTROL
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7.3 Access to the Facilities and Technical Visits; Payment for Technical Assistance.
7.3.1 During the TECHNOLOGY TRANSFER, PROTALIX shall have the right to enter the FACILITIES, during normal business hours to check and verify the FACILITY, DRUG SUBSTANCES, PRODUCTS, SUPPLIED MATERIALS and any MANUFACTURING processes, quality control standards and other activities relating to the foregoing or this AGREEMENT that are performed at the FACILITY to ensure compliance with this AGREEMENT (including compliance with the SPECIFICATIONS, GMP standards, and applicable Brazilian LAW and achievement of COMPLETION REQUIREMENTS). FIOCRUZ shall implement any mitigation plan reasonably identified by PROTALIX to address any such findings.
7.3.2 FIOCRUZ shall allow PROTALIX and/or its representatives/designees reasonable access to the FACILITIES and to its records in order to enable PROTALIX to conduct periodic reviews during normal business hours of the health and safety practices and performance of the FACILITIES. In connection with such audit or evaluation, FIOCRUZ shall cooperate in the completion of a Health & Safety survey by PROTALIX or in the scheduling of a Health & Safety audit of any FACILITY, as applicable. FIOCRUZ shall correct, at its own cost and expense, any material deficiencies in its health and safety management practices that are identified to it. FIOCRUZ acknowledges that such reviews and evaluations conducted by PROTALIX are for the benefit of PROTALIX only and are not a substitute for FIOCRUZ’s own health and safety management obligations under this AGREEMENT and, accordingly, FIOCRUZ may not rely upon them.
ARTICLE 9. ROYALTY, REPORTING AND PAYMENT TERMS
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9.2 Royalty Reporting and Payment. Not later than thirty (30) days after the end of each calendar quarter during the Term (a “REPORTING PERIOD“), FIOCRUZ shall (a) submit to PROTALIX a written report setting forth in reasonable detail (i) gross sales of FINAL Product during the Reporting Period, (ii) Net Sales and number of units of FINAL Product sold or distributed during the Reporting Period, as well as the computation of such Net Sales amounts, (iii) inventory of FINAL PRODUCT at the beginning and end of such Reporting Period, and (iv) all other information related to the business of FIOCRUZ during such Reporting Period to the extent necessary to enable the calculation of amounts payable hereunder to be verified, and (b) pay PROTALIX all amounts due for such Reporting Period.
ARTICLE 14. BOOKS AND RECORDS
14.1 FIOCRUZ shall keep and maintain during the TERM and for one (1) years after the termination of this AGREEMENT, accurate and correct books and records setting forth gross sales of the PRODUCTS, Net Sales, number of units of PRODUCT sold, inventory of PRODUCT and all other information related to the business of FIOCRUZ necessary to enable the calculation of amounts payable hereunder to be verified and the confirmation of FIOCRUZ’s compliance with this AGREEMENT. PROTALIX shall have the right to request that an independent accountant reasonably selected by it examine FIOCRUZ’s books and records at any reasonable time, upon reasonable notice and at the Facilities or other facilities where such books and records are normally kept. The opinion of such independent accountants regarding such payments shall be binding on the PARTIES, other than in the case of manifest error. Except as set forth below, the auditing PARTY shall bear the cost of any such examination and review.
14.2 If the review of FIOCRUZ’s records reveals that FIOCRUZ failed to accurately report information pursuant to Article 9.2 or otherwise underpaid any amounts due hereunder, then FIOCRUZ shall promptly pay PROTALIX the amount of any underpayment due hereunder, which shall be subject to all additional charges mentioned in Article 9.4 above, including the default interest at the Rate. If such discrepancy is greater than five percent (5%) of the amount due, FIOCRUZ shall promptly reimburse all costs incurred by PROTALIX in connection with such examination.
