5.01 Supply; Diligence
Licensees shall have the sole responsibility to Supply the Licensed Product in the Territory consistent with the Objectives and the Supply Plan and its sole cost and expense. Licensees will use its Best Efforts to Supply the Licensed Product within the Territory.
5.02 Supply Plan
a) Supply Plan. Within fifteen (15) days after the Effective Date, the Parties (through the JSC) will submit a comprehensive written a preliminary commercialization plan setting forth all Supply activities to be undertaken by or on behalf of Licensees and the estimated timelines applicable to such activities (the “Supply Plan”) to the JSC for analysis, discussion and suggestions. Licensees undertake to update and refine such preliminary Supply Plan to annually provide AstraZeneca with its Supply Plan to provide most accurate estimate, in relation to the anticipated quantities and terms, and in doing so it must use your best Commercially Reasonable Efforts. Licensees must inform AstraZeneca in writing of any material changes to its Supply Plan. At all times during the Term, Licensees will Supply the Licensed Product in accordance with the Supply Plan.
b) Amendments. The JSC will periodically review, and, as required, prepare suggestions of amendments to the initial Supply Plan, for review and discussion by the JSC. The amended Supply Plan will become effective and supersede the previous Supply Plan as of the date Licensees submit the new version of the Supply Plan Amendments to the Supply Plan will only be effectives if made pursuant to this Section 5.02(b).
c) Supply Reporting. Licensees will provide the JSC with written reports detailing its Supply activities under the Supply Plan at least ten (10) days in advance of each regularly scheduled JSC meeting. The Parties will discuss the status, progress and results of such Supply Activities under the Supply Plan at such regularly scheduled JSC meetings. Notwithstanding the foregoing, Licensees shall notify AstraZeneca promptly upon becoming aware of any information that would reasonably be expected to be material to the Supply of the Licensed Product in the Territory.
5.03 No Sales Outside the Territory
For the avoidance of doubt, neither Licensees nor any Licensees’ Sublicensee may directly or indirectly Supply the Licensed Product in any jurisdiction outside of the Territory, except when expressly authorized by AstraZeneca, especially for humanitarian purposes to meet the demand of international organizations, such as WHO, OPAS, UNICEF, among others. Licensee shall requires that all third parties to which it sells or supplies Licensed Product in accordance with this Agreement will not Supply the Licensed Product outside the Territory. Furthermore, Licensee shall put in place reasonable safeguards to ensure that none of the Licensed Product that it Commercializes pursuant to this Agreement are sold outside of the Territory.
Licensees shall be responsible for establishing, and managing Manufacture of, the Licensed Product, as well as engaging their Best Efforts to Manufacture the Licensed Product in an amount sufficient to meet demand for the Licensed Product in the Territory, as required by the demand formalized by the Ministry of Health.
5.06 Manufacturing Plan
Manufacturing Plan. The estimate of the Manufacturing activities of the Licensed Product shall be sent by Licensees to AstraZeneca four times a year (March, June, September and December), and Licensees shall provide AstraZeneca with a fifteen (15)-day advance notice in writing of any relevant change to such Manufacturing Plan, expect when the concrete case previous notice as described herein is not viable.
a) Amendments. The JSC will periodically review, and, as required, prepare recommendations to the Manufacturing Plan to Licensees.
b) Manufacturing Reporting. Licensees will provide the JSC with written reports detailing its Manufacturing activities under the Manufacturing Plan at least ten (10) days in advance of each regularly scheduled JSC meeting. The Parties will discuss the status, progress and results of such Manufacturing Activities under the Manufacturing Plan at such regularly scheduled JSC meetings. Notwithstanding the foregoing, Licensees shall notify AstraZeneca promptly within a reasonable term upon becoming aware of any information that would reasonably be expected to be material to the Manufacturing of the Licensed Product in the Territory.
c) Manufacturing Records. Licensees will maintain complete, current and accurate records of all Manufacturing activities conducted by it hereunder and all information results in from such activities, which records shall include: (i) all records required to be maintained under Applicable Law; (ii) batch records, validation data, stability testing data and quality control data; (iii) a reasonably detailed description of the processes and procedures followed; and (iv) a description of the implementation of any relevant improvements.
5.10 Supply Rights
a) In case Licensees, in view of (i) problems in the Manufacturing of the Licensed Product at Licensees premises; (ii) need to expand the Manufacturing capacity to meet the demand for the Licensed Product in the Territory; or (ii) delays in the execution of the Technology Transfer Work Plan, Manufacturing Plan, Supply Plan and Regulatory Plan, notify AstraZeneca about such instances mentioned above, AstraZeneca or any third party under AstraZeneca’s responsibility may, according to demand, availability and delivery schedule by the time of the order, agree to manufacture and commercialize the Licensed Product or the IFA [API] in the Territory to Licensees, pursuant to conditions to be negotiated in good faith between the Parties which must be the subject matter of a separate agreement.