Provision Language
Novartis – MPP Agreement
7. Liability and Indemnity
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7.5. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES REGARDING MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OF INTELLECTUAL PROPERTY OR OTHER THIRD PARTY RIGHTS, VALIDITY OR ENFORCEABILITY OF INTELLECTUAL PROPERTY RIGHTS, THE GRANT OF ANY PENDING PATENT APPLICATIONS, OR RELEVANCE OF THE MANUFACTURING PATENT OR THE PATENTS TO THE PRODUCTS, ARE MADE OR GIVEN BY OR ON BEHALF OF NOVARTIS AND, EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
9. Compliance
9.1. Each Party agrees that it shall comply fully at all times with all applicable laws and regulations, including but not limited to drugs’ safety, pharmacovigilance, anti-corruption laws, and that it has not, and covenants that it will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorise, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting it or the other Party in obtaining or retaining business, or in any way with the purpose or effect of public or commercial bribery, and warrants that it has taken reasonable measures to prevent subcontractors, agents and any other Third Parties, subject to its control or determining influence, from doing so.
9.2. Each Party represents and warrants, to the best of its knowledge, that in connection with this Agreement, it respects the human rights of its staff and does not employ child labor, forced labor, unsafe working conditions, or cruel or abusive disciplinary practices in the workplace and that it does not discriminate against any workers on any ground (including race, religion, disability, gender, sexual orientation or gender identity); and that it pays each employee at least the minimum wage, provides each employee with all legally mandated benefits, and complies with the laws on working hours and employment rights in the countries in which it operates. Each Party shall be respectful of its employees’ right to freedom of association and shall encourage compliance with these standards by any supplier of goods or services that it uses in performing its obligations under this Agreement.
Form of Sublicense
15. WARRANTIES, INDEMNITIES, COMPLIANCE WITH LAW
15.1 Each of the Parties warrants that, to the best of its knowledge and belief: it has power to execute and deliver this Agreement and to perform its
(a) obligations under it and has taken all action necessary to authorise such execution and delivery and the performance of such obligations; and
(b) this Agreement constitutes legal, valid and binding obligations of that Party in accordance with its terms.
15.2 The Licensee warrants that the Licensee has independently evaluated any information supplied by the Licensor and Novartis (including, but not limited to, such information related to the Products), as well as the viability of this Agreement, before making its decision to enter into this Agreement and to undertake the commitments and obligations set forth herein.
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15.5 The Licensee represents and warrants that it respects the human rights of its staff and does not employ child labor, forced labor, unsafe working conditions, or cruel or abusive disciplinary practices in the workplace and that it does not discriminate against any workers on any ground (including race, religion, disability, gender, sexual orientation or gender identity) and aims to achieve greater equity along those lines in the workplace; and that it pays each employee at least the minimum wage, provides each employee with all legally mandated benefits, and complies with the laws on working hours and employment rights in the countries in which it operates.
15.6 The Licensee shall be respectful of its employees’ right to freedom of association and shall encourage compliance with the standards referred to in Clause 15.5 by any supplier of goods or services that it uses in performing its obligations under this Agreement.
15.7 The Licensee shall comply fully at all times with all applicable laws and regulations, including but not limited to drugs’ safety, pharmacovigilance, anti-corruption laws, and that it has not, and covenants that it will not, in connection with the performance of this Agreement, directly or indirectly, make, promise, authorise, ratify or offer to make, or take any act in furtherance of any payment or transfer of anything of value for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; or improperly assisting in obtaining or retaining business, or in any way with the purpose or effect of public or commercial bribery, and warrants that it has taken reasonable measures to prevent subcontractors, agents and any other Third Parties, subject to its control or determining influence, from doing so.
15.8 The Licensee shall manufacture and sell the Products in accordance with all laws and regulations relevant to the manufacture and sale of the Products and in accordance with good industry practice, including without limitation GMP and GDP.
15.9 Further, the Licensor warrants that Novartis has warranted in the Head Licence that Novartis did not conduct any studies to determine whether any salt, hydrate or polymorph of nilotinib other than crystal Form B of the monohydrochloride monohydrate salt of nilotinib (active ingredient of Tasigna®) has the same food effect and/or QT prolongation as Tasigna or whether any product containing a form other than the crystal Form B of the monohydrochloride monohydrate salt of nilotinib (active ingredient of Tasigna) can be safely administered to patients by dispersing the content in apple sauce. Novartis reserves the right to share this information with relevant Regulatory Authorities.