Integrated Product Plans. Within [***], Praxis will prepare and provide to Ionis an integrated Product plan outlining key aspects of the Product Development (including CMC-related matters) as well as key aspects of its regulatory strategy, market launch and Commercialization (including annual sales forecasts) (such plan, an “Integrated Product Plan” or “IPP”), which plan will include the components set forth in SCHEDULE 8.2. Once Praxis has prepared the initial IPP, Praxis will update the IPP annually; provided, however, reports on these topics prepared by Praxis for internal management purposes will be sufficient to satisfy this updating obligation, in which case Praxis may redact information that is unrelated to the Product. Praxis and Ionis will meet on a [***] basis to discuss the updated IPP provided by Praxis to Ionis pursuant to the prior sentence. Praxis will consider, in good faith, any proposals and comments made by Ionis for incorporation in the IPP. In addition, upon reasonable request of Ionis (but in no event more than once per Calendar Quarter) following the dissolution of the JSC, Praxis will make a senior member of its commercial leadership team available at least [***] in advance of Ionis’ quarterly earnings release (provided Ionis has given Praxis the expected date of each such earnings release), to answer questions from Ionis’ Alliance Manager related to any material changes that may have occurred to the IPP, or otherwise to Praxis’ commercialization or regulatory strategy with respect to the Product, since the last [***] update of the IPP was provided to Ionis. The Parties’ Alliance Managers will coordinate and plan such meetings.
Integrated Product Plans. For each Licensed Program, AstraZeneca will prepare a global integrated Product plan or a comparable document consistent with AstraZeneca’s then current internal practices for AstraZeneca’s internal programs outlining key aspects of the Development of the Product being Developed from such Program as well as, as Development proceeds, and such information is available, key aspects of worldwide regulatory strategy, pricing and market access strategy, market launch, and Commercialization (each plan or other such document, an “Integrated Product Plan” or “IPP”). AstraZeneca will prepare each IPP no later than [***] for the relevant Product, and the IPP will contain high level information consistent with AstraZeneca’s development and commercialization plans for its similar products at similar stages of development and commercialization in the same AstraZeneca franchise. Once AstraZeneca has prepared an IPP, AstraZeneca will update it consistent with AstraZeneca’s standard practice (including if the IPP is updated and presented to an AstraZeneca internal committee) but at least Annually and will provide such updates to Isis. AstraZeneca and Xxxx will meet (through the JSC or as the Parties may otherwise agree) on an Annual basis to discuss the draft of the IPP and AstraZeneca will consider, in good faith, any proposals and comments made by Isis for incorporation in the IPP.
Integrated Product Plans. AstraZeneca will prepare a Development and global integrated Product plan or a comparable document consistent with AstraZeneca’s then current internal practices for AstraZeneca’s internal programs outlining key aspects of the Development of each Product licensed by AstraZeneca under Section 6.1.1, Section 6.1.2 and Section 6.1.3 through all Approvals as well as, as Development proceeds and when such information is available, key aspects of worldwide regulatory strategy, pricing and market access strategy, market launch, and Commercialization (each plan or other such document, an “Integrated Development Plan” or “IDP”). On a Product-by-Product basis, for each Product licensed by AstraZeneca under Section 6.1.1, Section 6.1.2 or Section 6.1.3, as the case may be, AstraZeneca will prepare each IDP no later than [***] for such Product, and the IDP will contain high level information consistent with AstraZeneca’s development and commercialization plans for its similar products at similar stages of development and commercialization in the same AstraZeneca franchise, including material updates, timelines, goals, and the criteria AstraZeneca will use to make internal decisions relating to the Product, provided however that it will be at AstraZeneca’s sole discretion whether to and in what format to provide any information which (i) AstraZeneca is required not to share even under confidentiality pursuant to restrictions imposed by any Third Party, or (ii) contains AstraZeneca Confidential Information regarding the use of AstraZeneca’s other portfolio compounds used alone or in combination with other AstraZeneca or Third Party products. Once AstraZeneca has prepared an IDP, AstraZeneca will update it consistent with AstraZeneca’s standard practice (including if the IDP is updated and presented to an AstraZeneca internal committee) but at least Annually and will provide such updates to Ionis. AstraZeneca and Ionis will meet (through the JSC or as the Parties may otherwise agree) on a yearly basis to discuss the draft of the IDP and AstraZeneca will consider, in good faith, any proposals and comments made by Ionis for incorporation in the final IDP. AstraZeneca and Ionis will [***], to discuss the status of execution of the IDP. Additionally, subject to any restrictions imposed by any Third Party, AstraZeneca may provide more frequent updates in the case of extraordinary material events (e.g. approvals, regulatory feedback, etc.) as deemed appropriate by AstraZeneca. ...
