Master Alliance Provisions Guide (MAPGuide)

AbbVie – MPP, HIV Antiretroviral (lopinavir, ritonavir – LPV/r) License Agreement

  • Business model | Quality management

3. Sublicense

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3.3 Sublicensee Certification. MPP shall only enter into sublicenses with entities that have produced reasonable evidence demonstrating (i) their intent and capability to comply with applicable laws relating to corruption (including anti–bribery laws and the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act 2010) and (ii) where such licensee obtains the right to manufacture Licensed Compounds or Licensed Products, their capability to engage in such manufacture in a manner consistent with (a) World Health Organization pre-qualification standards; or (ii) the standards of any applicable regulatory authority which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.