Roche Territory. Roche shall have the sole right and responsibility for Medical Affairs Activities in support of Licensed Products in the Roche Territory. Roche shall use Commercially Reasonable Efforts to perform Medical Affairs Activities in support of Licensed Products in the Roche Territory and will provide annual plans, amendments and status reports to the JMAC for review and discussion.
Roche Territory. Roche (and its Affiliates and Sublicensees) shall have the right to file in its own name, and to own, all Regulatory Materials and Regulatory Approvals for Licensed Products in the Roche Territory. Roche shall provide BPM with reasonable advance notice of any scheduled meeting (whether such meeting is in-person, by teleconference, or otherwise) with respect to such matter with any Regulatory Authority in the Major Countries [***] and BPM shall have the right to participate in any such meeting, to the extent permitted by Applicable Law, with the representatives of Roche taking the lead as the primary spokespeople at such meetings with Regulatory Authorities. Roche shall provide to BPM annual updates of its Regulatory Interactions, including updates with respect to filings of Regulatory Materials made, meetings held with Regulatory Authorities, and Regulatory Approvals received in the Roche Territory and shall respond to reasonable requests by BPM for additional information. Effective [***], BPM hereby assigns and transfers to Roche all Regulatory Materials and Regulatory Approvals for Licensed Products in the Roche Territory to Roche, in each case, that is in the possession or Control of BPM. Each Party will submit all filings, letters and other documentation necessary to effect such assignments and transfers to the Regulatory Authority in the Roche Territory. Until [***], BPM shall be responsible for and handle all matters related to the Licensed Products involving a Regulatory Authority in the EU, to the extent not yet assigned and transferred to Roche, and shall keep Roche informed of all regulatory matters relating to any Licensed Product in the EU. The Parties shall follow EMA guidance for the transfer of the MAA in the EU. Analogous procedures will be followed for other countries in the Roche Territory where BPM has already submitted an MAA.
Roche Territory. Roche shall use Commercially Reasonable Efforts to Commercialize [***] Compounds and Licensed Products in the Roche Territory, and to carry out the tasks specified under the Roche Operational Plan in a timely manner, and shall conduct its activities in compliance in all material respects with Applicable Law and applicable codes of conduct in each country within the Roche Territory.
Roche Territory. With respect to Compounds and Licensed Products, Roche shall be responsible for one hundred percent (100%) of all costs and expenses incurred by Roche and its Affiliates and Sublicensees with respect to Commercialization thereof in the Roche Territory.
Roche Territory. 6 Section 1.29 Territory................................................................................6 Section 1.30 Trade Dress..............................................................................6 Section 1.31 Trademark(s).............................................................................6 Section 1.32 United States............................................................................6 TABLE OF CONTENTS (Continued) Page No.
Roche Territory. 6 Section 1.31
Roche Territory. If either Party becomes aware of any Regulatory Authority that raises a Product Action Concern with respect to, or in, the Roche Territory, then such Party shall notify the other Party in writing of such event within [****] Business Days (or sooner if required by Applicable Laws) after such Party becomes aware of the Product Action Concern. Following receipt of such written notice, the Parties will discuss and attempt to agree upon whether to recall or withdraw the applicable Product for use in the Field in the Roche Territory; provided, however, that if the Parties fail to agree within an appropriate time period [****].
Roche Territory. Roche shall at all times conduct Commercialization of Products in the Field in the Roche Territory in accordance with the Global Brand Strategy. Roche shall provide informational updates to the JCC of its plans for Commercialization activities for Products for use in the Roche Territory on an annual basis (no later than once every [****], and shall respond in a timely fashion to any reasonable requests of Alnylam with respect to such plans and Commercialization activities in the Roche Territory. Roche will consider in good faith Alnylam’s input on such plans; provided that for clarity, Roche shall have final decision making authority at the JCC with respect to Commercialization of Products in the Roche Territory in accordance with Section 2.5(d)(ii)(3).
Roche Territory. Roche shall be solely responsible for developing the Promotional Materials and Disease Awareness Materials for use by Roche in the Commercialization of the Products for use in the Field in the Roche Territory. Roche may develop the Promotional Materials and Disease Awareness Materials for the Products for use in the Field in the Roche Territory that are different than the Promotional Materials and Disease Awareness Materials used in the Co-Commercialization Territory; provided that such Promotional Materials, Disease Awareness Materials, and all related promotional practices, including detailing, distribution of study reprints, interactions with healthcare practitioners, sample distribution, voucher programs, and any payments made to healthcare practitioners to serve as speakers or on advisory boards (i) include, with equal prominence, the names and logos of both Parties, (ii) are consistent with the applicable Product labeling, the Global Brand Strategy and the Core Promotional Materials and Core Disease Awareness Materials, as applicable,
Roche Territory. Following the Technology Transfer Completion Date, Roche will be responsible (either itself or through an Affiliate or one or more [****]) for the Manufacture of all quantities of Therapeutic Product for Commercialization of the Product for use in the Field in the Roche Territory. Alnylam shall Manufacture and supply the REVERSIR Product for Commercialization for use in the Field in the Roche Territory which shall be included in the Commercial Supply Agreement, and the REVERSIR Product will not be part of the Technology Transfer to Roche under Section 6.8.
