Co-Commercialization Territory. The Parties shall develop promotional materials for use in the Co-Commercialization Territory by both Parties and their Affiliates that comply with each Party’s applicable policies, SOPs, the Co-Commercialization Plan, and Applicable Laws and Regulatory Approvals. Copies of all promotional materials used by COMPANY and MorphoSys and their Affiliates in the Co-Commercialization Territory shall be archived by COMPANY and/or MorphoSys, as applicable, in accordance with applicable Laws. The promotional materials developed by the Parties shall be reviewed and approved by the JCC. The JCC shall establish and implement a review process to ensure that both Parties’ compliance officers and legal departments certify compliance of the promotional materials with applicable Laws and policies of the Parties. If the Parties cannot agree upon the content of a particular promotional material, the matter may be referred to the legal departments of the Parties, and then to the JCC for resolution, subject to the final approval of the Parties’ respective compliance officers and legal departments. If the Parties’ compliance officers or legal departments are unable to mutually approve the content of a particular promotional material in accordance with the immediately preceding sentence, then such promotional material shall include the content approved by the Party with the more conservative compliance or legal position regarding such content. The Parties shall jointly own all right, title and interest in and to any promotional materials created hereunder relating to the Product(s) in the Co-Commercialization Territory. Promotional material in the Co-Commercialization Territory shall include logos of MorphoSys and COMPANY (or the other entity marketing the Product) at equal size.
Co-Commercialization Territory. Each Party will use Commercially Reasonable Efforts to: (a) seek and obtain Regulatory Approval for at least [***] and (ii) [***], in each case ((i) and (ii)), [***]; and (b) [***].
Co-Commercialization Territory. Each Party (and in the case of Xxxxxx, to the extent permitted under this Definitive LRRK2 Agreement) will use Commercially Reasonable Efforts to seek and obtain Regulatory Approval for at least [***], in each case ((i) and (ii)), [***].
Co-Commercialization Territory. If either Party becomes aware of any Regulatory Authority that (i) has threatened, initiated or advised any action to remove any Product for use in the Field from the market or (ii) has required or advised Alnylam, Roche, or any of their Related Parties to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Field (collectively, a “Product Action Concern”), in each case ((i) and (ii)) with respect to, or in, the Co-Commercialization 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 Co-Commercialization Territory in response to such Product Action Concern; provided, however, that if the Parties fail to agree within an appropriate time period [****].
Co-Commercialization Territory. Alnylam shall be responsible, either itself or through any of its Affiliates or CMOs, for the Manufacture of quantities of Products required for Commercialization (for clarity, including Post-Approval Studies) in the Co-Commercialization Territory pursuant to the Commercial Supply Agreement. No later than [****] years prior to the anticipated date of First Commercial Sale of the Product for use in the Field in the Co-Commercialization Territory (as agreed upon by the Parties through the JCC), the Parties shall negotiate in good faith and enter into a commercial supply agreement (the “Commercial Supply Agreement” and, together with the Clinical Supply Agreement, the “Supply Agreements”), for the Manufacture and supply by or on behalf of Alnylam or any of its Affiliates (including a CMO) to Roche of quantities of Products for Commercialization of the Products for use in the Field in the Co-Commercialization Territory. The Commercial Supply Agreement shall contain those terms set forth on Exhibit D (the “Commercial Supply Term Sheet”), terms consistent with the allocation of Commercial Supply Costs as part of shared Net Profits and Net Losses as set forth in Section 8.3 and the Financial Appendix, and such other reasonable customary terms agreed upon by the Parties in writing. For the avoidance of doubt, the terms and conditions to be included in the Commercial Supply Agreement shall not be subject to Roche’s or Alnylam’s final decision-making authority under Section 2.5(d)(i) or Section 2.5(d)(ii), as applicable.
Co-Commercialization Territory. Each Party (and in the case of Denali, to the extent permitted under this Definitive LRRK2 Agreement) will use Commercially Reasonable Efforts to: (a) seek and obtain Regulatory Approval for at least [***], in each case ((i) and (ii)), [***].
