Provision Language
AbbVie – MPP Agreement
4. MPP Obligations
4.1 Monitoring of Compliance. MPP agrees to monitor compliance with each Sublicense by each Sublicensee. Such monitoring shall include:
(a) reviewing with all reasonable skill and care any reports provided to MPP by the Sublicensee under Sections 3.5 and 10.2 of the Sublicense;
(b) within 30 days of the expiry of the ten Business Day period referred to in Section 10.2 of the Sublicense, assessing in relation to each Sublicensee whether the supplies of Licensed Products made in the relevant Agreement Quarter were made in accordance with the terms of the Sublicense and this Agreement, and promptly reporting the outcome of such assessment to AbbVie; and
(c) fully exercising the audit right set out in Section 10.1 of the Sublicense at MPP’s own cost as soon as MPP has reasonable cause to believe (or as soon as AbbVie and MPP have agreed that they have reasonable cause to believe) an audit is necessary.
4.2 Reports. MPP will send to AbbVie within 30 days following the end of each calendar quarter (i) the number of units of Licensed Products sold by strength / formulation by country, and (ii) the amount of Licensed Compound manufactured under this Agreement for the purpose of making Licensed Products. MPP shall also provide AbbVie with a quarterly written report setting forth each Sublicensee’s (a) Licensed Products development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan with the WHO Pre-qualification Programme or a Stringent Regulatory Authority (“Stringent Regulatory Authority”), defined as regulatory authorities which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, as may be updated from time to time for each Licensed Product, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained for any Licensed Product. AbbVie agrees that information contained in quarterly and other such reports shall be treated as Confidential Information.
4.3 Audit. MPP grants AbbVie the right, with reasonable notice, to: (a) inspect and audit the performance of, and compliance with, this Agreement and applicable laws; and (b) inspect and audit all documents and other records relating to the performance of this Agreement. MPP will cooperate with and provide all reasonable assistance to AbbVie, its officers, employees, agents, advisors, representatives or contractors exercising AbbVie’s rights under this Section 4.3. AbbVie will provide MPP with a commercially reasonable period of notice of the proposed audit; provided, however, dispute as to such notice shall not limit MPP’s obligations under this section. The parties agree that such audits will not be conducted more than once in any 12-month period, unless the prior audit has shown evidence of the failure of MPP or a Sublicensee to perform in compliance with this Agreement or with applicable laws.
4.4 Notification of Breach. If MPP becomes aware of any act or omission of a Sublicensee which constitutes a breach of the relevant Sublicense MPP shall immediately notify AbbVie and (i) if the breach is capable of correction and does not give rise to an immediate right of termination under the Sublicense, direct the relevant Sublicensee in writing to cure the breach; and (ii) if the breach remains uncured at the end of the specified period, or if there are otherwise grounds for termination under the Sublicense, terminate the relevant Sublicense in accordance with its terms.
[…]
4.6 Pharmacovigilance. If MPP or any Sublicensee becomes aware of any adverse reaction relating to the Licensed Products in connection with this Agreement or a Sublicense Agreement, MPP or the relevant Sublicensee shall inform AbbVie within 24 hours of its becoming aware and cooperate with AbbVie in fulfilling AbbVie’s reporting responsibilities under applicable laws and regulations.
Form of Sublicense
6. Non-Diversion
[…]
6.4 Audit. Licensee shall permit Licensor and AbbVie, individually or together, to: (i) inspect and audit the performance of, and compliance with, this Agreement and the AbbVie-MPP Agreement and applicable laws; and (ii) inspect and audit all documents and other records relating to the performance of this Agreement and the Sublicenses. Licensee will cooperate with and provide all reasonable assistance to AbbVie or Licensor and their officers, employees, agents, advisors, representatives or contractors exercising the rights of AbbVie and Licensor under this Section 6.4. AbbVie or Licensor will provide Licensee with a commercially reasonable period of notice of the proposed audit; provided, however, dispute as to such notice shall not limit Licensee’s obligations under this section. AbbVie and Licensor, each individually, agree that such audits will not be conducted more than once in any 12-month period, unless the prior audit has shown evidence of the failure of Licensee to perform in compliance with this Agreement, the AbbVie-MPP Agreement or applicable laws.
10. Statements and Remittances
10.1 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 for the previous two years (or for the period from the Effective Date to the then current date if such period is less than two years) of all quantities of Licensed Compounds and Licensed Products manufactured or sold under the licenses granted by this Agreement, together with that information contemplated by Section 10.2. The Licensor shall have the right (and the Licensee shall procure such right), at its expense, through a certified public accountant or like person appointed by it, to examine such records during regular business hours during the term of this Agreement and for six months after its termination or expiry; provided, however, that such examination shall not take place more often than twice in any calendar year and shall not cover such records for more than the preceding two calendar years and provided further that such accountant or like person shall report to Licensor only as to:
(a) the accuracy of the manufacturing and sales statements of the Licensee (and its Affiliates and its third party manufacturers contemplated by this Agreement) in relation to such manufacture and sales;
(b) the appropriateness of quantities of Licensed Compounds and Licensed Products imported or manufactured pursuant to this Agreement by reference to what quantities of Licensed Compounds and Licensed Products would reasonably be required to meet demand for actual sales made and sales forecasted by the Licensee;
(c) verification that all sales and other supplies of Licensed Compounds and Licensed Products made by the Licensee have been made in the Territory, except for Licensed Compounds and Licensed Products made outside the Territory as expressly provided for in this Agreement;
(d) verification that all sales and other supplies of Licensed Compounds and Licensed Products made by Third Party manufacturers contemplated by this Agreement have been made to the Licensee in accordance with this Agreement.
10.2 Within 10 Business Days following the end of each Agreement Quarter, the Licensee shall deliver to Licensor a statement accounting for all Licensed Products (in terms of smallest units and patient packs for each formulation) sold or supplied by the Licensee under this Agreement during such Agreement Quarter in the Reporting Template as set forth in Exhibit D, as well as the amount of Licensed Compound manufactured under this Agreement for the purpose of making Licensed Products. Licensor agrees that information contained in quarterly and other such reports shall be treated as Confidential Information, provided, however, that such information may be shared with AbbVie (with AbbVie treating such reports as Confidential Information); and that aggregated data may be publicly disclosed by Licensor.