Prior to First Commercial Sale. Within 60 days after the end of each CY prior to First Commercial Sale, Licensee shall furnish Licensor with a written report on the progress of its efforts during the immediately preceding CY to develop and commercialize Licensed Products. The report shall also contain a discussion of intended efforts for the calendar year in which the report is submitted.
Prior to First Commercial Sale. Each of the Parties agree that prior to the First Commercial Sale of the Licensed Product, neither Party will issue any announcements, releases, statements or reports, or confirm any statements made by Third Parties, pertaining to this Agreement or the transactions contemplated hereby, unless agreed to in writing by the other party, except as may be required by law or otherwise permitted herein. ALTUS and FALK will jointly discuss and must first agree in writing before makxxx any statement to the public regarding this Agreement and the results of Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 406 of the Securities Act. clinical studies conducted hereunder. When a Party elects to make any such statement it will give the other Party at least five (5) business day's notice, unless disclosure is required by law in a shorter period of time, and allow the other Party to review and comment on such statement. The Parties acknowledge the importance of supporting each other's efforts to publicly disclose results and significant developments regarding the Licensed Product. The principles to be observed by ALTUS and FALK in such public disclosures will be: accuracy, the requirements xxx confidentiality under Article 10, the advantage a competitor of ALTUS or FALK may gain from any public statements under this Section 13.6, anx xxe standards and customs in the biotechnology and pharmaceutical industries for such disclosures by companies comparable to ALTUS and FALK. The terms of this Agreement may also be disclosed to (a) goverxxxxt agencies where required by law, including filings required to be made by law with the Securities and Exchange Commission, or any national securities exchange or quotation system, (b) Third Parties with the prior written consent of the other Party, which consent shall not be unreasonably withheld, and (c) investors and potential investors, lenders and potential lenders, and any other sources of potential financing for either Party; provided, however, that in the case of (b) and (c) above, such disclosure is made under a binder of confidentiality at least as restrictive as the confidentiality provisions in Section 10.1 above (in the case of Third Parties), so long as highly sensitive terms and conditions such as financial terms are extracted from the Agreement or not disclosed upon the request of the ot...
Prior to First Commercial Sale. During the Term up to First Commercial Sale of the Product, River Vision shall have the obligation to submit detailed annual reports to Roche summarizing development progress of the Product, including the Development Plan, pursuant to Section 5.1. The first such annual report shall be provided on the first anniversary of the Effective Date. Each subsequent annual report shall be provided on subsequent anniversaries of the Effective Date.
Prior to First Commercial Sale. If, prior to First Commercial Sale of the first Product in the Territory, the ROCHE Group ceases all activities with regards to all Compounds and Products, then ROCHE shall (i) inform EVOTEC accordingly and (ii) if EVOTEC informs ROCHE of its decision to continue development and commercialization of Compounds and Products, license to EVOTEC the ROCHE Patent Rights and ROCHE Know-How, (which will include the Patent Rights and Know-How generated by EVOTEC under the License Agreement, including the Joint Patent Rights, if any), relating to Compounds and Products in the Field in the Territory, and transfer to EVOTEC all Patent Rights and Know-How that were included in the Assets relating to Compounds within clause (ii) of the definition of “Compound” in Section 1.10 or relating to Products containing such a Compound. ROCHE shall, upon EVOTEC’s written request, to the extent it has the right to do so, transfer to EVOTEC, at no expense to EVOTEC, all regulatory filings and regulatory approvals, trademarks, and all data, including clinical data, materials and information, in ROCHE’s possession and control related to Compounds and Products. In such case, the terms of the License Agreement shall apply, including future event payments and royalties. Upon the request of EVOTEC, ROCHE shall complete any clinical studies related to the Products that are being conducted under its IND for the Products and are ongoing as of the effective date of termination; provided, however, that
(a) ROCHE may agree but shall have no obligation to recruit or enroll any additional patients after the ceasing of all activities under this Section 17.1; and
(b) EVOTEC agrees to reimburse ROCHE for all of its development costs which arise in completing such studies.
Prior to First Commercial Sale. During the Agreement Term up to First Commercial Sale of the Product, Dermira shall submit detailed annual reports to Roche describing in detail the development progress of the Product, including any revisions proposed to be made to the Development Plan for the then current Calendar Year, pursuant to Section 5.2. Dermira shall send such annual report within [*****] ([*****]) days after the end of December of each Calendar Year. Until [*****], Dermira shall provide [*****] updates to Roche regarding recruitment progress for the Phase II Dose-finding Study.
Prior to First Commercial Sale. For each Calendar Year up to and including the Calendar Year in which First Commercial Sale of the R/F/TAF Product in the Territory occurs:
(a) the R/F/TAF Product Working Percentage of Gilead shall equal one hundred percent minus the R/F/TAF Product Working Percentage of Xxxxxxx; and
(b) the R/F/TAF Product Working Percentage of Xxxxxxx shall equal [*]. Such R/F/TAF Product Working Percentages for a given Calendar Year shall be calculated by Gilead and notified to Xxxxxxx as promptly as practicable thereafter.
Prior to First Commercial Sale. Licensee shall submit to PHS within sixty (60) days after each calendar year ending December 31 a royalty report setting forth for the preceding year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due. With each such royalty report, Licensee shall submit payment of the earned royalties due. If no earned royalties are due to PHS for any reporting period the written report shall so state. After First Commercial Sale, Licensee shall submit to PHS within sixty (60) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth the preceding half-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed Territory, the Net Sales, and the amount of royalty accordingly due. With each such royalty report, Licensee shall submit payment of the earned royalties due. If no earned royalties are due to PHS for any reporting period the written report shall so state. Any royalty report submitted pursuant to this paragraph shall be certified as correct by an authorized officer of Licensee and shall include a detailed listing of all deductions made under Paragraph 2.10 to determine Net Sales made under Article 6 to determine royalties due.
Prior to First Commercial Sale. Neurocrine may terminate this Agreement for convenience in its entirety or in one or more (but not all) of the Major Markets, provided that for purposes of this Section 14.2 (Termination for Convenience), [***], on six months’ written notice to Takeda (a) with respect to all Licensed Products prior to the First Commercial Sale of the first Licensed Product for which First Commercial Sale occurs in the Territory or the applicable Major Market(s), or (b) with respect to all Licensed Products in one or more given Target Classes prior to the First Commercial Sale of the first Licensed Product in such Target Class(es) for which First Commercial Sale occurs in the Territory or the applicable Major Market(s).
Prior to First Commercial Sale. Prior to the First Commercial Sale of the Licensed Products in the Territory, MGI shall maintain a global adverse event database for the Product worldwide and shall be responsible for compliance with all applicable laws relating to adverse event reporting and the conduct of clinical trials and reporting obligations relating thereto required by the applicable laws worldwide (including annual safety reports, periodic safety update reports and quarterly line listings).
Prior to First Commercial Sale. Takeda may terminate this Agreement for convenience in its entirety or on a Product-by-Product basis in [***], upon [***] written notice to Arrowhead prior to the First Commercial Sale of the first Product for which First Commercial Sale occurs in the Territory or the applicable Major Market(s).
