Common use of Commercialization Reports Clause in Contracts

Commercialization Reports. Jounce will, with Celgene’s cooperation with respect to its activities under the U.S. Commercialization Plan, provide the JCC with a report, as soon as practicable but in no event later than [***] following the end of each Calendar Quarter commencing as of and continuing after the Calendar Quarter in which the first Co-Co Product has received Regulatory Approval in the United States setting forth a summary written progress report on the status of its Commercialization Activities with respect to Co-Co Products and Co-Co Diagnostic Products, including the number of details made by any sales representatives of Co-Co Product in the United States during such Calendar Quarter (a “U.S. Commercialization Report”), as well as Jounce’s plans with respect to Commercialization of Co-Co Products and Co-Co Diagnostic Products during the following [***] period. At least [***] prior to the anticipated First Co-Co Sale of a Co-Co Product under this Jounce Lead Co-Co Agreement in the United States, the JCC shall discuss and agree upon the form and content for such U.S. Commercialization Report. Such U.S. Commercialization Report shall also describe in reasonable detail the number of sales representatives dedicated to Commercialization of such products, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect to such products, actual and projected sales of such products, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by the JCC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Appears in 2 contracts

Sources: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)

Commercialization Reports. Jounce Celgene will, with CelgeneJounce’s cooperation CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. with respect to its activities under the U.S. Commercialization Plan, provide the JCC with a report, as soon as practicable but in no event later than [***] days following the end of each Calendar Quarter commencing as of and continuing after the Calendar Quarter in which the first Co-Co Product has received Regulatory Approval in the United States setting forth a summary written progress report on the status of its Commercialization Activities with respect to Co-Co Products and Co-Co Diagnostic Products, including the number of details made by any sales representatives of Co-Co Product in the United States during such Calendar Quarter (a “U.S. Commercialization Report”), as well as JounceCelgene’s plans with respect to Commercialization of Co-Co Products and Co-Co Diagnostic Products during the following [***] period. At least [***] prior to the anticipated First Co-Co Sale of a Co-Co Product under this Jounce Celgene Lead Co-Co Agreement in the United States, the JCC shall discuss and agree upon the form and content for such U.S. Commercialization Report. Such U.S. Commercialization Report shall also describe in reasonable detail the number of sales representatives dedicated to Commercialization of such products, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect to such products, actual and projected sales of such products, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by the JCC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

Appears in 2 contracts

Sources: Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.), Master Research and Collaboration Agreement (Jounce Therapeutics, Inc.)

Commercialization Reports. Jounce willWithin thirty (30) days of December 31 of each year following the first anniversary of the Effective Date and continuing until such time as Company (either directly or through its Sublicensee) begins providing University with sales reports pursuant to Section 6.3 below, with Celgene’s cooperation with respect the Company shall deliver to the University written reports of the Company's and its activities under Material Sublicensees' efforts and plans to commercialize the U.S. Commercialization PlanLicensed Technology and to manufacture, provide the JCC with a offer to sell, or sell Licensed Products. In such written report, as soon as practicable but in no event later than [***] following Company will provide University a general description of the end activities of Company and each Calendar Quarter commencing as of and continuing after the Calendar Quarter in which the first Co-Co Product has received Regulatory Approval Material Sublicensee. Company further agrees in the United States setting forth a summary written progress report on case of Sublicenses granted to Sublicensees that are not Material Sublicensees, that Company will provide University with the status name of the Sublicensee and general description of the general type of work (e.g., contract manufacturing, monitoring of clinical trials, etc.) being performed under each such Sublicense. Company's inability to disclose any plans of its Commercialization Activities Sublicensees shall not relieve the Company of its obligations to demonstrate its compliance with respect its diligence obligations under Section 5.1 above including for each of the commercialization and performance milestones described in Section A5.1 of attached Exhibit A, each commercialization report shall include sufficient information to Co-Co Products demonstrate compliance of those milestones and Co-Co Diagnostic Products, including the number shall set out timeframes and plans for those milestones which have not yet been met. Company further agrees to include in each such commercialization report a list of details made all Sublicenses granted by any sales representatives of Co-Co Product in the United States during such Calendar Quarter (a “U.S. Commercialization Report”), as well as Jounce’s plans with respect to Commercialization of Co-Co Products and Co-Co Diagnostic Products Company during the following [***] periodpreceding calendar year. At least [***] prior Upon University's request, Company shall provide a list of wholesalers and resellers with rights to the anticipated First Cosell Licensed Product. Company further agrees that it will provide University a verbal and in-Co Sale of a Co-Co Product under this Jounce Lead Co-Co Agreement in the United Statesperson update as to progress against milestones every three (3) months until such time as Company has achieved Qualified Funding. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, the JCC shall discuss and agree upon the form and content for such U.S. Commercialization ReportAS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. Such U.S. Commercialization Report shall also describe in reasonable detail the number of sales representatives dedicated to Commercialization of such productsACCORDINGLY, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect to such products, actual and projected sales of such products, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by the JCC. CERTAIN THE CONFIDENTIAL PORTIONS OF HAVE BEEN OMITTED FROM THIS EXHIBIT WERE OMITTED EXHIBIT, AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDCOMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.

Appears in 1 contract

Sources: Exclusive Patent License Agreement (Phaserx, Inc.)

Commercialization Reports. Jounce willAfter the First Commercial Sale of a Licensed Product anywhere in the Territory, with Celgene’s cooperation with respect LICENSEE shall submit to its activities under the U.S. Commercialization Plan, provide the JCC with a report, as soon as practicable but in no event later than [***] following the end Cornell semi-annual reports on or before each February 28 and August 31 of each Calendar Quarter commencing as of year. Each report shall cover LICENSEE’s (and continuing after the Calendar Quarter in which the first Coeach Affiliate’s and Sublicensee’s) most recently completed calendar half-Co Product has received Regulatory Approval in the United States setting forth a summary written progress report on the status of its Commercialization Activities with respect to Co-Co Products year and Co-Co Diagnostic Products, including shall show: (i) the number of details made by any each type of Licensed Product sold; (ii) the gross sales representatives and Net Sales during the most recently completed calendar half-year, an explanation of Coall deductions under Net Sales as defined in Paragraph 1.27, and the royalties, in US dollars, payable with respect thereto; [ *** ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. (iii) Sublicense Fees received during the most recently completed calendar half-Co year and all amounts deducted under the exceptions in Paragraph 1.42 and explanations therefor, all in US dollars, and the amount payable with respect thereto; (iv) the method used to calculate the royalties and Sublicense Fee payments; (v) the exchange rates used; and (vi) relevant business and corporate development efforts relating to the rights granted in this Agreement and to the diligence development efforts described herein. LICENSEE shall provide the above information using the form as shown in Appendix I and include information on the date of the First Commercial Sale of each Licensed Product in each country. If, following the United States during such Calendar Quarter (a “U.S. Commercialization Report”), as well as Jounce’s plans with respect to Commercialization of Co-Co Products and Co-Co Diagnostic Products during the following [***] period. At least [***] prior to the anticipated First Co-Co Commercial Sale of a Co-Co Product under this Jounce Lead Co-Co Agreement in the United StatesLicensed Product, the JCC shall discuss and agree upon the form and content for such U.S. Commercialization Report. Such U.S. Commercialization Report shall also describe in reasonable detail the number of sales representatives dedicated to Commercialization of such products, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect to such products, actual and projected no sales of such productsLicensed Products have been made or no Sublicense Fees has been received by LICENSEE during any reporting period, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by the JCC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDEDLICENSEE shall so report.

Appears in 1 contract

Sources: License Agreement (Lexeo Therapeutics, Inc.)

Commercialization Reports. Jounce willAt each meeting of the JCC, with Celgene’s cooperation Licensee will report on the Commercialization activities Licensee has performed or caused to be performed in the Territory since the last meeting of the JCC, evaluate the work performed in relation to the goals of the Commercialization Plan and provide such other information as may be required by the Commercialization Plan or reasonably requested by the JCC with respect to its such Commercialization activities. If Licensee fails to adequately provide such report at a meeting of the JCC, Nogra may request, and Licensee will provide to Nogra, a written progress report that describes Commercialization activities under that Licensee has performed or caused to be performed since the U.S. last meeting of the JCC, evaluate the work performed in relation to the goals of the Commercialization PlanPlan and provide such other information as may be required by the Commercialization Plan or reasonably requested by Nogra to permit Nogra to obtain a reasonably comprehensive understanding of the status and performance of the applicable Commercialization activities with respect to Licensed Products in the Territory. The JCC will evaluate Licensee’s performance each Calendar Quarter during which Commercialization activities with respect to the Licensed Products in the Field are performed in the Territory against the Commercialization Plan and provide a report of such progress to the JSC at each quarterly meeting of the JSC. In addition, provide Licensee will regularly meet with Nogra prior to the JCC with a report, as soon as practicable but in no event later than date [***] following the end after First Commercial Sale of each Calendar Quarter commencing as of and continuing after the Calendar Quarter in which the first Co-Co Product has received Regulatory Approval in the United States setting forth a summary written progress report on the status of its Commercialization Activities with respect to Co-Co Products and Co-Co Diagnostic Products, including the number of details made by any sales representatives of Co-Co Licensed Product in the United States during such Calendar Quarter Territory (a “U.S. Commercialization Report”)and thereafter at Nogra’s reasonable request, as well as Jounce’s plans with respect up to Commercialization of Co-Co Products and Co-Co Diagnostic Products during the following [***] period. At least [***] prior per year), to review the anticipated First Co-Co Sale of a Co-Co Product under this Jounce Lead Co-Co Agreement activities that Licensee has undertaken with regard to Commercializing the Licensed Products in the United StatesField in the Territory. Further, the JCC shall discuss and agree upon the form and content for such U.S. Commercialization Report. Such U.S. Commercialization Report shall also describe in reasonable detail the number of sales representatives dedicated Licensee will provide notice to Commercialization of such products, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect to such products, actual and projected sales of such products, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by Nogra (through the JCC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED) if Licensee elects to suspend or no longer proceed with Commercializing any Licensed Compounds or Licensed Products or any of the Primary Indications.

Appears in 1 contract

Sources: License Agreement (Celgene Corp /De/)

Commercialization Reports. Jounce will(a) Beginning on the date that is *** after the date of initiation of clinical studies with a Product intended by GSK to be the subject of a Regulatory Approval Application, with Celgene’s cooperation GSK will deliver to ALLERGAN, within thirty (30) calendar days after such date and, thereafter, within ***, a written marketing plan with respect to its activities under commercialization by GSK of Product in the U.S. Commercialization Plan, provide Field of Use in the JCC with a report, as soon as practicable but in no event later than [Territory that is the subject of the Regulatory Approval Application. (b) Approximately *** prior to the anticipated date of commercialization of a Product in such Field of Use, GSK will deliver to ALLERGAN a complete marketing plan including market analysis and marketing and sales activities in the Territory, the date anticipated by GSK that such marketing and sales activities will begin, and, after Regulatory Approval for Product has been obtained for such Field of Use, marketing and sales information with respect to such Product for such Indication in the Territory; provided, however, that GSK will not be required to generate extensive commercial analysis solely for the purpose of reporting. Such annual reports will be in addition to the written reports concerning progress in development described in Section 5.9. 1. GSK may delete proprietary and sensitive information describing GSK's customer and marketing strategies from reports to be provided to ALLERGAN under this Section 5.9.2. (c) After the GSK Sales Commencement Date, GSK shall provide to ALLERGAN, within *] following ** after the end of each Calendar Quarter commencing as of and continuing after the Calendar Quarter in which the first Co-Co Product has received Regulatory Approval in the United States setting forth a summary written progress report on the status of its Commercialization Activities with respect to Co-Co Products and Co-Co Diagnostic Products, including the number of details made by any sales representatives of Co-Co Product in the United States during such Calendar Quarter (a “U.S. Commercialization Report”), as well as Jounce’s plans with respect to Commercialization of Co-Co Products and Co-Co Diagnostic Products during the following [***] period. At least [, a written report of GSK's estimated Net Sales in the Territory during the immediately preceding ***] prior to . (d) Within *** after the anticipated First Co-Co Sale end of a Co-Co Product under this Jounce Lead Co-Co Agreement in the United States, the JCC shall discuss and agree upon the form and content for such U.S. Commercialization Report. Such U.S. Commercialization Report shall also describe in reasonable detail the number of sales representatives dedicated to Commercialization of such products, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect to such products, actual and projected sales of such products, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by the JCC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[each ***]”, GSK shall provide to ALLERGAN a written report of the estimated Net Sales of GSK in the Territory during the immediately preceding ***, broken down into two (2) categories: aggregate Net Sales for the Cosmetic Indications and aggregate Net Sales for all Indications other than the Cosmetic Indications. (e) ALLERGAN acknowledges and agrees that the written reports received from GSK in accordance with Sections 5.9.2(c) and (d): (i) are estimates of Net Sales only, and thus by definition may contain inherent errors, and will not be binding upon and/or create any diligence obligation on GSK and/or any of its Affiliates or sublicensees for any purpose under this Agreement; (ii) are being provided to ALLERGAN solely for information purposes and that as a result, neither GSK nor any of its Affiliates or sublicensees will be liable for, and ALLERGAN will indemnify and hold GSK, its Affiliates and sublicensees harmless from and against, any liabilities, damages, losses, costs and/or expenses of any kind whatsoever incurred by ALLERGAN, its Affiliates, its sublicensees or any Person relating to the use of such written reports by ALLERGAN, its Affiliates and/or its sublicensees whether internally or publicly, subject to Section 5.9.5; (iii) may be amended by GSK, its Affiliates or sublicensees at any time and for any reason whatsoever; and (iv) are not subject to being audited by ALLERGAN or its Affiliates or sublicensees. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933Further ALLERGAN acknowledges and agrees *** Certain confidential information contained in this document, AS AMENDEDmarked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. that it cannot obligate GSK to alter or amend in any way any written report received from GSK in accordance with Sections 5.9.2(c) and (d).

Appears in 1 contract

Sources: License Agreement (Allergan Inc)

Commercialization Reports. Jounce will, with Celgene’s cooperation with respect to its activities under the U.S. Commercialization Plan, provide the JCC with a report, as soon as practicable but in no event later than (i) Within [***] days following the end of each Calendar Quarter commencing as of and continuing after the Calendar Quarter in which for the first Co-Co Product has received Regulatory Approval in the United States setting forth a summary written progress report on the status of its Commercialization Activities with respect to Co-Co Products and Co-Co Diagnostic Products, including the number of details made by any sales representatives of Co-Co Product in the United States during such Calendar Quarter (a “U.S. Commercialization Report”), as well as Jounce’s plans with respect to Commercialization of Co-Co Products and Co-Co Diagnostic Products during the following [***] periodCalendar Years occurring after Regulatory Approval for the first Licensed Product in the Territory is obtained, and (ii) within [***] days following the end of the [***] Calendar Quarter during each Calendar Year thereafter until the end of the Term, Qilu shall submit to Arbutus a report summarizing in reasonable detail Qilu’s and its Affiliates’ and permitted Sublicensees’ activities related to (x) the Commercialization of the Licensed Products during the preceding Calendar Quarter(s), and (y) the Manufacture of the Licensed Compound and Licensed Products during the preceding Calendar Quarter, including (A) an update on Qilu’s plans for the Manufacture and supply of the Licensed Compound and Licensed Products, including supply for raw materials and components and any Third Party suppliers and CMOs to be included as part of such plans, and (B) a summary of any material Manufacturing-related milestones that were in process or were achieved during the preceding Calendar Quarter, including the status of any technology transfer, process validation, etc. Arbutus shall have the opportunity to discuss each such report and its contents with Qilu, either through the JSC or in any other manner reasonably acceptable to both Parties, and Qilu shall provide to Arbutus any additional documentation or information reasonably requested by Arbutus relating to such reports. (b) At least [***] prior to the anticipated First Co-Co Commercial Sale of a Co-Co Licensed Product under this Jounce Lead Co-Co Agreement in the United StatesField in the Territory, the JCC Qilu shall discuss and agree upon the form and content submit to Arbutus its proposed commercial launch plan for such U.S. Commercialization ReportLicensed Product for Arbutus’ review. Such U.S. Commercialization Report Following the delivery of the initial commercial launch plan, Qilu shall also describe in reasonable detail the number of sales representatives dedicated submit to Commercialization of such products, the detailing strategy for such products, advertising, marketing and other promotional activities being conducted for such products, educational and scientific presentations to be made with respect Arbutus an annual update to such products, actual and projected sales of such products, the key opinion leaders to be engaged with respect to such products, and other matters agreed upon by the JCC. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “plan within [***]”] days after the end of each Calendar Year. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933The initial commercial launch plan and each subsequent annual update shall include promotional plans, AS AMENDEDprojected timelines, pricing and contracting strategy, product position statement, communications strategy, and promotional efforts commitments. Upon the request of Arbutus from time to time after receipt of Regulatory Approval for the first Licensed Product in the Field in the Territory, Qilu shall provide to Arbutus (i) a copy of Qilu’s then-current marketing plan for the Licensed Products in the Field in the Territory, and (ii) copies of any marketing materials then being used by Qilu to market and promote the Licensed Products in the Field in the Territory, in each case of (i) and (ii), as then currently available and to the extent not previously provided.

Appears in 1 contract

Sources: Technology Transfer and Exclusive License Agreement (Arbutus Biopharma Corp)