24 set. 35 do Regulamento da ANVISA aprovado pelo Decreto nº , de 16 . natureza sanitária, na forma da Lei n° , de 20 de agosto de. Agency responsible: Brazilian Health Regulatory Agency (Anvisa) June , section 1, page 42, (2)Law , 20 August (Lei nº 13 dez. Rdc de anvisa guidelines ++ Lei n? , de Guideline for the Safe Transport of Infectious Substances and Diagnostic. Author.
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New York, NY Capitalized terms used but not defined herein have the respective meanings ascribed thereto in the Agreement. For good and valuable consideration the receipt and sufficiency of which 6347 and Protalix hereby acknowledge, Pfizer and Protalix hereby agree as follows: Payments pursuant to this paragraph 2 shall be made on a quarterly basis lie.
Pfizer and Protalix shall review the operating plan for Brazil on an annual basis, beginning with the first Joint Steering Committee meeting following approval of the Licensed Product for commercialization in Brazil. Protalix shall have the sole authority and exclusive right to determine all operating plans and strategies for the Drug Substance and Licensed Product in Brazil; provided that Protalix shall reasonably consider any comments on such plans and strategies that Llei may communicate through the Steering Committee or otherwise.
Pfizer also shall have the right to terminate the grant of rights to Protalix for Brazil contained herein and in the relevant Sections of anvis Agreement as amended hereby if the Technology Transfer Agreement between Protalix and Fiocruz terminates before completion of the contemplated technology transfer.
For the avoidance of doubt, as used in this Letter Amendment, the term “Commercialize” includes the activities referred to in Section 1. Allocation within and outside the Territory shall occur at the final step of shared production between Pfizer and Protalix, which will depend on where the supply chain segregates in the month of allocation; that is, allocation may describe any of Drug Substance or Licensed Product, depending on a given month such allocation priority, including as set forth herein, the ” Allocation Priority “.
Overages or excess inventory in a given month will be allocated to technical programs, inventory builds, and commercial sales as recommended and agreed upon by the Supply Chain Committee. Subject to and in accordance with the terms of this Section 5 and the Quality Agreement, Protalix shall supply all quantities of Drug Substance ordered by Pfizer under this Agreement for clinical and commercial use in the Field in the Territory.
The Agreement is hereby amended to replace the term “Allocation Percentage” with the term “Allocation Priority”, for each instance such term is referenced in the Agreement.
On the Effective Date, or such later date that allows for delivery outside of the Territory, Protalix shall issue to Pfizer an initial forecast the ” Initial Protalix Forecast ” for the four 4 calendar quarters commencing with the first quarter post approval of the Licensed Product for commercialization in Brazil, together with a firm purchase order for the first quarter for Licensed Product for delivery outside the Territory.
The quantities of Licensed Product deliveries specified for the following quarter of the Initial Protalix Forecast shall be binding and the remaining two 2 quarters for the Initial Protalix Forecast shall be non-binding.
Thereafter, ninety 90 days prior to the first business day of each subsequent calendar quarter, Protalix shall deliver to Pfizer a rolling four 4 calendar quarter forecast updating the prior forecast. The quantities of the Licensed Product deliveries for the following one 1 quarter shall be binding and the remaining two 2 quarters of such forecast shall be non-binding.
Purchase orders for material outside the Territory will be issued in accordance with the Manufacturing Service and Supply Agreement between Pfizer Inc. For the avoidance of doubt, until full completion of the Technology Transfer, as defined in the Technology Transfer Agreement, the Quality Agreement including the change control procedures outlined in the Quality Agreement shall apply to all proposed changes anvjsa the Drug Substance, Licensed Product manufacturing process and le with respect to all territories including Brazil, with the intention of ensuring one common Drug Substance and Licensed Product process across territories and fungible inventory, as practical.
Upon completion of the Technology Transfer, with respect to Brazil, Protalix shall reasonably consult with Pfizer regarding any proposed changes to the Drug Substance process with respect to Brazil, with the intention of ensuring one common Drug Substance process across territories and fungible inventory, such consultation as practical, but no less frequently than once per calendar year.
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Protalix shall use Commercially Reasonable Efforts to accommodate the suggestions of the Supply Chain Committee relating to any such proposed change, but shall retain sole discretion regarding whether any such proposed change shall be implemented with respect to Brazil, including implementation of any change that would create segregated specifications and inventories for Brazil.
For purposes of this Letter Amendment and solely for purposes of establishing the accounting and procedure anvksa payment in connection with the approval and commercialization of the Licensed Product in Brazil, i Section 7 of the Agreement is hereby amended to replace all references to “Pfizer” with “Protalix,” all references to “Protalix” with “Pfizer”, and all references to “the Territory” with “Brazil”; ii Navisa 7.
For all other purposes, Section 7 shall remain unchanged, except as set forth below. For purposes of this Letter Amendment and solely for purposes of establishing the accounting and procedure for payment in connection with the approval and commercialization of the Licensed Product in Brazil, Section 7.
For all purposes other than establishing the accounting and procedure for payment in connection with the approval and commercialization of the Licensed Product in Brazil, Section 7. For purposes of this Letter Amendment and the approval and commercialization of the Licensed Product in Brazil: Exhibit I is hereby deleted in its entirety and replaced with attached new Exhibit I hereto.
Notwithstanding any other termination right Pfizer has in the Agreement, Pfizer may terminate this Letter Amendment including the grant of rights to Protalix for Brazil contained herein and in relevant Sections of the Agreement as amended hereby if Protalix breaches For purposes of this Letter Amendment and solely for the calculation of Net Profits and Net Loss in connection with the approval and commercialization of the Licensed Product in Brazil, Exhibit E of the Agreement shall be amended to: Protalix or its designee Fiocruz shall have the right to file a marketing authorization application in Brazil and seek Regulatory Kei for such application for the Licensed Product.
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Protalix and its designee Fiocruz shall have the sole right to apply for and secure exclusivity rights that may be available under the Law of Brazil, including any Regulatory Exclusivity.
Pfizer shall use Commercially Reasonable Efforts to cooperate with Protalix and its designee Fiocruz and to take such reasonable actions to assist Protalix and its designee Fiocruz, in obtaining such exclusivity rights in Brazil, as Protalix or its designee Fiocruz may reasonably request from time to time. Until any marketing authorization application for Licensed Product submitted by Protalix or its designee Fiocruz is approved by the National Sanitary Surveillance Agency of the Brazilian Government or any successor or replacement agency that has the authority to grant the necessary Regulatory Approvals ” Anvisa ” and any other required Regulatory Approval is obtained by Protalix or its designee Fiocruz, and with respect to any Pfizer or Pfizer Affiliate Regulatory Approvals and regulatory filings including, without limitation, marketing authorizations in Brazil and related data: Protalix or its designee Fiocruz shall be entitled to have one or more representatives present at all such meetings unless prohibited by Applicable Law or unless reasonably impracticable under the circumstances.
Once Protalix or its designee Fiocruz has successfully received Regulatory Approval for the Licensed Product, Protalix shall have the sole authority and exclusive right to determine all regulatory plans and strategies for the Licensed Product in Brazil; provided that Protalix or its designee Fiocruz shall reasonably consider any comments on such plans and strategies that Pfizer may communicate through the Steering Committee or otherwise.
Protalix or one or more of its designated Affiliates or its designee Fiocruz will own its marketing authorization application and be responsible for preparing, seeking, submitting and maintaining all related regulatory commitments including filings and Regulatory Approvals for the Licensed Product in Brazil, including preparing all reports necessary as part of a regulatory filing or Regulatory Approval. Protalix is liable to Pfizer for all actual Pfizer costs associated with providing such transitional services, as defined in the TSA and agreed upon by the Parties as set forth herein, from the date of the execution of this Letter Amendment, which costs shall not, in any event, exceed the costs set forth on Exhibit F, unless otherwise expressly agreed in advance by Protalix and Pfizer in writing.
Notwithstanding the foregoing, Protalix shall be responsible for expenses relating to the engagement by Protalix of fully-dedicated medical personnel in Brazil to support the Licensed Product, as needed. Such written plan shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party to comply with applicable Laws, including any local regulatory requirements.
Pfizer acknowledges and agrees that, while this Letter Amendment is in effect, Protalix is permitted to sublicense to Fiocruz the Product Marks pursuant to the Technology Transfer Agreement for use as they exist on the labeling and packaging of finished packaged product at the time such finished packaged product is supplied to Fiocruz, and subject to the quality control provisions set forth in the Technology Transfer Agreement, which shall be at least as protective as those set forth in Section 4.
Pfizer acknowledges and agrees that, while this Letter Amendment is in effect, Protalix is permitted to sublicense to Fiocruz any drug product manufacturing-related enhancements to or new presentations of Licensed Product developed or otherwise owned by Pfizer or its Affiliates ” Pfizer Improvements “pursuant to the Technology Transfer Agreement, subject to the provisions set forth herein; provided that the Pfizer Improvements are used solely for the Licensed Product by Protalix and Fiocruz.
Such Technical Support shall consist only of the transfer of the technical manufacturing information, as well as access to and availability of Pfizer personnel knowledgeable with respect to the Pfizer Improvement, including consultation by phone.
Technical Support for each Pfizer Improvement will be limited to 40 person hours. Pfizer is not obligated to provide equipment, material, or additional people as part of Technical Support related to any Pfizer Improvement.
Should additional Technical Support be required beyond the 40 person hours to complete the transfer of the technical manufacturing information ” Additional Technical Support “Protalix shall provide to Pfizer a written request prior to initiation of such Additional Technical Support. Pfizer and Protalix must mutually agree on the Additional Technical Support. Pfizer and Protalix shall reasonably cooperate in good faith to execute any additional amendments or agreements, and take any other actions reasonably necessary to properly effectuate the terms and conditions of this Letter Amendment and to make the Agreement and any related agreements consistent with this Letter Amendment.
This Letter Amendment is not effective until the Technology Transfer Agreement in substantially the same form as of the date hereof has been signed by Protalix and Fiocruz and is in effect.
The terms and existence of this Letter Amendment including the Exhibits hereto and any negotiations between Pfizer and Protalix relating hereto shall be deemed the Confidential Information of both Pfizer and Protalix and shall be subject to the provisions of the Agreement relating to Confidential Information.
This Letter Amendment shall be governed lwi and construed in accordance with the substantive laws of the State of New York, without regard to conflicts of law rules.
The terms of the Agreement shall remain in full force and effect, other than as set forth in this Letter Amendment or pursuant to the terms of the Agreement. The provision of an unsigned draft of this Letter Amendment shall not be deemed an offer by, or create any obligation on behalf of, the party providing such draft. This Letter Amendment shall become effective only upon the execution of this Letter Amendment by both Pfizer and Protalix.
This Letter Amendment may be executed in any counterparts, each of which, when executed, shall be deemed to be an original and which together shall constitute one and the same document. Please indicate your agreement with the foregoing by countersigning a copy of this letter.
Accepted and agreed this 18th day of June, We expressly assume the commitment to and compliance with the standards and procedures of health legislation, as well as recognize the penalties to which we may be subject, pursuant to Law No. Valid for two years from issuance. Pfizer has a longstanding corporate policy that prohibits colleagues or anyone acting on our behalf from providing any payment or benefit to any person or entity in order to improperly influence a government official or to gain an unfair business advantage.
Pfizer is committed to performing with integrity, and acting ethically and legally in accordance with all applicable laws and regulations, including, but not limited to, anti-bribery and anti-corruption laws. Bribery of Government Officials. Most countries have laws that forbid making, offering or promising any payment or anything of value directly or indirectly to a government official when the payment is intended to influence an official act or decision to award or retain business.
The FCPA also prohibits a company or person from using another company or individual to engage in any of the foregoing activities. Business Associates must communicate and abide by the following principles with regard to their interactions with governments and government officials: Bribery and corruption can also occur in non-government, business to business relationships. Most countries have laws which prohibit offering, promising, giving, requesting, receiving, accepting, or agreeing to accept money or anything of value in exchange for an improper business advantage.
Examples of prohibited conduct could include, but are not limited to, the provision of inappropriate gifts or hospitality, kickbacks, or investment opportunities offered to improperly induce the purchase of goods or services. Pfizer colleagues are not permitted to offer, give, solicit or accept bribes, and we expect our Business Associates, and those acting on their behalf in connection with work for Pfizer, to abide by the same principles.
Business Associates must communicate and abide by the following principles with regard to their interactions with private parties and Pfizer colleagues: Diem Nguyen, General Manager, Biosimilars. It is understood and agreed between the Parties that any payments made by Protalix to Pfizer under this Agreement are exclusive of any value added or similar tax VATwhich shall be added thereon as applicable.
To the extent Protalix is required to deduct and withhold taxes on any payments to Pfizer, Protalix shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to Pfizer an official tax certificate or other evidence of such withholding sufficient to enable Pfizer to claim credits for such payments of taxes.
Pfizer shall provide to Protalix any tax forms that may be reasonably necessary in order for Protalix not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty.
Pfizer shall use reasonable efforts to provide any such tax forms to Protalix at least thirty 30 days prior to the due date for any payments for which Pfizer desires that Protalix apply a reduced withholding rate. Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by law, of withholding taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax.
Description of the health product: Business Associates, and those acting on their behalf in connection with work for Pfizer, may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any government official to induce that government official to make any governmental act or decision to help Pfizer obtain or retain business.
Business Associates, and those acting on their behalf in connection with work for Pfizer, need to understand whether local laws, regulations, or operating procedures including requirements imposed by government entities such as government-owned hospitals or research institutions impose any limits, restrictions, or disclosure requirements on compensation, financial support, donations, or gifts that may be provided to government officials.
Business Associates, and those acting on their behalf in connection with work for Pfizer, must take into account and comply with any applicable restrictions in conducting their Pfizer-related activities.
If a Business Associate is uncertain as to the meaning or applicability of any identified limits, restrictions, or disclosure requirements with respect to interactions with government officials, that Business Associate should consult with his or her primary Pfizer contact before undertaking their activities. Business Associates, and those acting on their behalf in connection with work for Pfizer, are not permitted to offer facilitation payments. Examples of facilitation payments include payments to expedite the processing of licenses, permits or visas for which all paperwork is in order.
In the event that a Business Associate, or someone acting on their behalf in connection with work for Pfizer, receives or becomes aware of a request or demand for a facilitation payment or bribe in connection with work for Pfizer, the Business Associate shall report such request or demand promptly to his or her primary Pfizer contact before taking any further action. Business Associates, and those acting on their behalf in connection with work for Pfizer, may not directly or indirectly make, promise, or authorize the making of a corrupt payment or provide anything of value to any person to induce that person to provide an unlawful business advantage for Pfizer.
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Business Associates, and those acting on their behalf in connection with work for Pfizer, may not directly or indirectly, solicit, agree to accept, or receive a payment or anything of value as an improper inducement in connection with their business activities performed for Pfizer.
Pfizer colleagues are not permitted to receive gifts, services, perks, entertainment, or other items of more than token or nominal monetary value from Business Associates, and those acting on their behalf in connection with work for Pfizer. Moreover, gifts of nominal value are only permitted if they are received on an infrequent basis and only at appropriate occasions.