Provision Language
Novartis – MPP Agreement
3. Licensee Selection Process
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3.2 During the Licensee Selection Process, MPP shall keep Novartis informed of the proposed Sublicensees and shall upon completion of the Licensee Selection Process promptly notify Novartis in writing of the entities MPP proposes to become the Sublicensees. Novartis shall within thirty (30) Calendar Days of such notification (acting reasonably) either approve or reject one or more of the proposed Sublicensees. For the avoidance of doubt if the proposed Sublicensee intends to use subcontractors including for supply of active ingredients, such subcontractor shall be approved by both MPP and Novartis as part of the Licensee Selection Process.
4. Reporting
Within 90 days after the end of each Agreement Quarter, MPP shall deliver a written report to Novartis consolidating the contents of all reports provided to MPP by each Sublicensee and setting out on a country-by-country, Sublicensee-by-Sublicensee and Product-by- Product basis in the Manufacturing Territory and Territory:
i. the total amount of Products sold and/or supplied by each Sublicensee on a country-by-country and pack type-by-pack type basis under the Sublicences for the immediately preceding Agreement Quarter incl. the royalty paid by the Sublicensee to be reinvested into the ATOM coalition.
ii. information on any regulatory activities including pharmacovigilance information as reported to MPP in accordance with each Sublicence;
iii. anti-bribery, environmental social governance and export control compliance.
6. Sublicence Compliance Monitoring – Audits
MPP shall, using all reasonable care, diligence and skill, actively monitor each Sublicensee’s compliance with the terms of its Sublicence, including:
(A) procuring that all Sublicensees provide the sales and royalty reports referred to in the Sublicence in a timely manner and in accordance with the terms the Sublicence. If, notwithstanding MPP’s efforts, a Sublicensee does not provide a sales report referred to in the Sublicence within five (5) Business Days after the required ten (10) Business Day period under the terms of the Sublicence, MPP shall notify Novartis of the same and provide details of its efforts to procure such sales report to date;
(B) procuring that all Sublicensees provide the regulatory reports referred to in the Sublicence in a timely manner and in accordance with the terms of the Sublicense. If, notwithstanding MPP’s efforts, a Sublicensee does not provide such a regulatory report, MPP shall notify Novartis of the same and provide details of its efforts to procure such regulatory report to date; and
(C) fully exercising the audit right set out the Sublicence at MPP’s or Novartis own cost as soon as MPP or Novartis has reasonable cause to believe an audit is necessary.
10. Confidentiality
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10.8. Novartis shall treat any unpublished information disclosed to it under the Sublicence as Confidential Information provided that Novartis shall be entitled to disclose information about the quantities of Products sold or supplied by Sublicensees on an aggregate basis provided such disclosure does not reveal any Confidential Information of any Sublicensee.
Form of Sublicense
3. QUARTERLY REPORTS
3.1 Within 10 Business Days following the end of each Agreement Quarter, the Licensee shall provide the Licensor with a written quarterly report, in a format to be indicated by MPP, on:
A. all Products (in terms of smallest units and patient packs for each formulation) on a country-by-country basis sold or supplied by the Licensee under this Agreement during such Agreement Quarter including royalties due as per Appendix D; and
B. all regulatory activities regarding the Products in the Territory in relation to that Agreement Quarter i.e. (a) the regulatory filing status and plan for every Product in the Territory, and (b) a list of the countries in the Territory in which applications for Regulatory Approval have been filed and/or Regulatory Approvals have been obtained for any Product; and
C. Products’ development timelines and the status of development including the Improvements, if any; and
D. environmental social governance, anti-bribery and trade compliance
3.2. The Parties agree to confer on a quarterly basis regarding such reports.
3.3. The Licensor agrees that information contained in quarterly and other such reports shall be treated as Confidential Information.
7. PHARMACOVIGILANCE
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7.2 Licensee will be responsible for fulfilling all pharmacovigilance activities as per the local regulations and requirements for the Products in the Territory and provide Licensor, at Licensor’s request, with a report containing information regarding all such activities upon reasonable request by the Licensor.
7.3 If Licensee becomes aware of any adverse reaction relating to the Products in connection with this Agreement, Licensee shall inform MPP and Novartis within 5 Business Day of it becoming aware and cooperate with Novartis in fulfilling Novartis’s reporting responsibilities under applicable laws and regulations.
12. AUDIT
12.1 At all times the Licensee shall keep, and shall require its Affiliates and any Third Party manufacturers and Third Parties making sales on its behalf, to keep, complete and accurate records in accordance with its Accounting Standards in relation to this Agreement for a period of five (5) years of all quantities of Raw Materials and Products manufactured, sold and/or supplied including Net Sales and royalties under the licences granted by this Agreement and such information of the type and in sufficient detail at MPP’s discretion.
12.2 The Licensor and Novartis shall each have the right (and the Licensee shall procure such right), through a certified public accountant or like person appointed by it, to examine such records in order to verify the compliance with this Agreement during regular business hours during the term of this Agreement and for six months after its termination or expiry; provided, however, that such examination:
(i) shall be at the expense of the person exercising such right (save where such examination reveals a breach of this Agreement by the Licensee, or an underpayment by Licensee of more than five percent (5%) of the total payments due for the applicable audit period is discovered, in which cases the Licensee shall pay for all costs incurred by Novartis and/or the Licensor in carrying out the examination),
(j) not take place more often than twice in any Calendar Year and shall not cover such records for more than the preceding five Calendar Years.