Participation in Regulatory Meetings. (a) Praxis will provide Ionis with as much advance notice as practicable of any meetings that Praxis has or plans to have with a Regulatory Authority in Major Market countries regarding pre-approval or Approval matters for a Product, and will invite up to two representatives of Ionis to participate in any such meetings under the direction of Praxis; provided, however, that, Praxis may exclude Ionis from any portion of such meeting that does not pertain to the Product or to Ionis’ antisense oligonucleotide chemistry platform. In addition, Praxis will provide Ionis with as much advance notice as practicable of any meetings that Praxis has or plans to have with a Regulatory Authority that directly relate to Ionis’ antisense oligonucleotide chemistry platform and will invite up to two Ionis representatives to participate in any such meetings [***].
Participation in Regulatory Meetings. Each Party will provide the other Party with as much advance written notice as practicable of any meetings such Party has or plans to have with a Regulatory Authority regarding pre-approval or Approval matters for a Product (or, in the case of Xxxx as the invitee, that relate to Xxxx’ antisense oligonucleotide platform), and, subject to Section 5.2, will allow one representative of the invited Party to participate (as an observer) in any such meeting that is [***] (e.g., meetings regarding [***]). The costs associated with such observer attendance will be met by the invitee Party, except if Xxxx’ presence has been specifically requested by AstraZeneca, in which case AstraZeneca will reimburse Isis for its time incurred in attending at the FTE Rate. To the extent that AstraZeneca has not fully used the [***] available to it pursuant to Section 4.8.1 or Section 5.3.3, then AstraZeneca will be entitled to allocate such [***] to the activities to be performed by Xxxx pursuant to this Section 5.3.1.
Participation in Regulatory Meetings. Subject to Section 18.6, and to the extent permitted by Applicable Law, CRISPR will have the opportunity to designate, by written notice to Vertex, one of its Senior-Level Employees to attend as an observer [***]. CRISPR will comply with Vertex’s internal policies disclosed to CRISPR regarding attendance and participation in such meetings, conferences and discussions.
Participation in Regulatory Meetings. For each Collaboration Program, each Party will conduct its interactions and communications with Regulatory Authorities in accordance with Section 5.2.
Participation in Regulatory Meetings. Each Party will provide the other Party with as much advance written notice as practicable of any meetings such Party has or plans to have with a Regulatory Authority regarding pre-approval or Approval matters for a Product, and will allow the other Party (at such other Party’s own expense) to participate in any such meetings as an observer.
Participation in Regulatory Meetings. On a Collaboration Program-by-Collaboration Program basis, following Option exercise for a particular Collaboration Program, Biogen will provide Ionis with as much advance written notice as practicable of any meetings that Biogen has or plans to have with a Regulatory Authority regarding pre-approval or Approval matters for such Product or that directly relate to Ionis’ antisense oligonucleotide chemistry platform, and will allow [***] of Ionis to participate in any such meetings at the direction of Biogen; provided, however, that Biogen may exclude Ionis from any portion of such meeting that does not pertain to such Product or to Ionis’ antisense oligonucleotide chemistry platform.
Participation in Regulatory Meetings. Prior to any scheduled meeting with a Regulatory Authority regarding a Product [***] (i) the Parties will discuss the timing and objectives for such meeting, and (ii) the Party who is the IND-holder will provide the other Party with an opportunity to discuss the strategy for such meeting with the IND-holder it being understood that the IND-holder shall have the right to set the timeline for such discussions between the Parties and that the IND-holder shall have the final decision-making authority regarding [***]. In addition, the IND-holder will allow the other Party to participate [***] in any such meeting with a Regulatory Authority [ ***] as an [***] unless the Regulatory Authority expresses its preference that such other Party should not participate in such meeting. Upon request of the IND-holder the respective other Party shall participate in any meetings with the Regulatory Authority and at all times support the IND-holder in a timely manner with respect to its obligations under this Section 6.2.
Participation in Regulatory Meetings. Ionis will provide Roche with as much advance written notice as practicable of any meetings that Ionis has or plans to have with a Regulatory Authority regarding the Proposed Phase 2 Trials and any other Phase 2 Trial or earlier stage Clinical Study that the Parties agree Ionis will conduct for a Product and will allow Roche (at Roche’s own expense) to participate in any such meetings as an observer.
Participation in Regulatory Meetings. Each Party will provide the other Party with as much advance written notice as practicable of any meetings such Party has or plans to have with a Regulatory Authority regarding pre-approval or Approval matters for a Product and will allow the other Party (at such other Party’s own expense) to participate in any such meetings as an observer. After Option exercise and upon transfer of the IND for IONIS-FB-LRx to Roche, Roche will lead all interactions with Regulatory Authorities regarding IONIS-FB-LRx and Products.
Participation in Regulatory Meetings. During the Option Period for each Collaboration Program, each Party will conduct its interactions and communications with Regulatory Authorities in accordance with Section 5.2.
