Bioscience. in each case, will be responsible to (i) maintain, at its (or PHARMA’s, as applicable) own cost and expense, the regulatory Approval in full force and effect, (ii) maintain a pharmacovigilance database, and (iii) respond appropriately to all relevant queries of any Regulatory Authority in the Territory. Notwithstanding BIOSCIENCE’s responsibility to this clause 10.5, INC will, upon reasonable request of BIOSCIENCE, render BIOSCIENCE, or, at the request of BIOSCIENCE, PHARMA, all reasonable support relating to any regulatory issues relating to the Territory. In particular, INC shall fully cooperate in all aspects relating to pharmacovigilance and product recalls.
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Sources: License and Supply Agreement (Biofrontera Inc.), License and Supply Agreement (Biofrontera Inc.)
Bioscience. in each case, will be responsible to (i) maintain, at its (or PHARMA’s, as applicable) own cost and expense, the regulatory Approval in full force and effect, (ii) maintain a pharmacovigilance database, and (iii) respond appropriately to all relevant queries of any Regulatory Authority in the Territory. Notwithstanding BIOSCIENCE’s responsibility to this clause 10.5, INC will, upon reasonable request of BIOSCIENCEBIOSCIENCE or PHARMA, render BIOSCIENCEBIOSCIENCE or PHARMA, or, at the request of BIOSCIENCE, PHARMAas applicable, all reasonable support relating to any regulatory issues relating to the Territory. In particular, INC shall fully cooperate in all aspects relating to pharmacovigilance and product recalls.
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