Roche’s Obligations Clause Samples
The "Roche’s Obligations" clause defines the specific duties and responsibilities that Roche, as a party to the agreement, is required to fulfill. This may include obligations such as providing certain products or services, meeting delivery timelines, maintaining quality standards, or supplying necessary information to the other party. By clearly outlining what is expected from Roche, this clause ensures accountability and helps prevent misunderstandings or disputes regarding Roche’s role and performance under the contract.
Roche’s Obligations. Roche will promptly, accurately and completely list, with the applicable Regulatory Authorities during the Agreement Term, all applicable Patent Rights that Cover a Product. Prior to such listings, the Parties will meet, through the Joint Patent Committee, to evaluate and identify all applicable Patent Rights, and Roche will have the right to review, where reasonable, original records relating to any invention for which Patent Rights are being considered by the Joint Patent Committee for any such listing. Notwithstanding the preceding sentence, Roche will retain final decision-making authority as to the listing of all applicable Patent Rights for a Product that are not Isis Core Technology Patents or Isis Manufacturing and Analytical Patents, regardless of which Party owns such Patent Rights.
Roche’s Obligations. 8.1 Roche shall procure and maintain all necessary FDA or other Regulatory Approvals for the manufacture, sale and use of Fuzeon within the Territory.
8.2 Roche will consign to Chronimed all of Chronimed's requirements of Fuzeon necessary to support all Enrolled Patients, subject to the distribution management processes identified herein, Roche's supply constraints, clinical trial supplies, and possible inventory requirement modifications as determined by Roche.
8.3 Roche will pay Chronimed for the Chronimed services identified in EXHIBIT C, CHRONIMED PRICING, according to the terms of this Agreement and EXHIBIT C.
8.4 Roche will be solely responsible for determining the patient eligibility requirements, if any, identified in EXHIBIT B, PATIENT WAIT LIST. In the event Roche deems it necessary to modify the eligibility criteria during the Term of this Agreement, Roche shall provide Chronimed with not less than 60 days prior notice of such modification.
8.5 Roche will maintain an Enrolled Patient hardship program consistent with the criteria identified in EXHIBIT I, ROCHE PATIENT ASSISTANCE PROGRAM. In the event an Enrolled Patient is admitted to Roche's hardship program, Chronimed shall be reimbursed for its services to such patient according to the terms of EXHIBIT E, TRANSACTION ADJUSTMENTS.
8.6 Roche shall initially bear the expense of any Fuzeon recall or product alert, whether ordered by the FDA or undertaken by Roche upon its own initiative. Expenses shall include costs associated with patient notification, product return shipping, and reasonable staffing time and expense to facilitate the recall. The ultimate allocation of recall expense will be determined by the respective fault of the parties by reason of their acts or negligence which contribute to the need for such recall.
8.7 Roche warrants that it will manufacture Fuzeon in accordance with FDA manufacturing requirements, with the Fuzeon specifications for which FDA approval has been or will be obtained, and in compliance with any other applicable regulatory