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恆瑞醫藥(600276.SH)與司太立協議就碘海醇注射液及碘帕醇注射液的生產、供應及商業化運營開展合作
格隆匯 05-12 18:58

格隆匯5月12日丨恆瑞醫藥(600276.SH)公佈,公司於2020年5月11日與浙江司太立製藥股份有限公司(“浙江司太立”)、上海司太立製藥有限公司(“上海司太立”,浙江司太立和上海司太立合稱“司太立”)簽署合作協議。上海司太立已就碘海醇注射液及碘帕醇注射液(“合作產品”)向中國國家藥品監督管理局(“NMPA”)提交了註冊申報,目前均處於受理階段;恆瑞和司太立協議就合作產品的生產、供應及商業化運營開展合作。

司太立將負責研發並註冊符合NMPA或其他領域內藥品相關監管部門(以下統稱“藥監部門”)要求的合作產品,並保證合作產品不侵犯任何第三方專利、商業祕密等知識產權,研發及註冊費用由司太立自行承擔。司太立應盡最大努力,完成所有需要的合作產品研發及註冊工作,獲得合作產品生產、銷售所需要的任何許可性文件。合作產品獲批上市後,雙方均應自費採取一切必要措施保證合作產品批件持續有效,相關必要措施包括但不限於對合作產品的生產設施採取藥監部門要求或建議的任何措施。

恆瑞應盡合理商業努力在中華人民共和國(為協議目的,不包括香港特別行政區、澳門特別行政區、台灣)(“領域”)內對合作產品進行商業化運作,包括營銷、自行或與經銷商合作銷售。恆瑞應自行決定此類商業合作產品的商業化運作方式和範圍,包括決定標籤、銷售合同、條款和價格。恆瑞應當提供自有品牌及商標,用以合作產品銷售,銷售款項由恆瑞全額收取。恆瑞認為合作產品開展商業化運作具有潛在風險的,應與司太立就延遲啟動銷售合作產品進行協商。

恆瑞與司太立建立互惠互利、共同發展的合作關係,依託司太立研發的合作產品與恆瑞強大的商業化運營優勢,互利共贏,符合各自的戰略發展需要,有利於加深恆瑞和司太立在碘造影劑領域的合作與發展。

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