Device Program Plans Sample Clauses

Device Program Plans. (i) The Parties agree that, as of the Effective Date, the Development Plan for the Therapeutic Product will include Development activities [****]. From time to time, during the Term, each Party shall have the right to propose to the JDC that the Development Plan be amended to include a device, [****], for administration of any Product for use in the Field (each such device, an “Administration Device”) in the Co-Commercialization Territory or in the Roche Territory by submitting a written proposal to the JDC describing the proposed Administration Device and anticipated costs and timelines with respect thereto, in sufficient detail for such Party to consider for inclusion in the Development Plan (each such proposal, a “Device Program Plan”). (ii) Following a Party’s submission of a Device Program Plan to the JDC in accordance with Section 3.5(c)(i), the JDC shall, at its next regularly scheduled meeting, review and determine whether to modify or amend such Device Program Plan. In the event that the JDC accepts such Device Program Plan (as modified or amended, as applicable), then the JDC shall recommend such Device Program Plan for consideration by the JSC for inclusion in the Development Plan (with any modifications or amendments agreed upon by the JDC) by providing the JSC with such Device Program Plan. Following the JDC’s submission of a Device Program Plan to the JSC in accordance with this Section 3.5(c)(ii), the JSC shall, at its next regularly scheduled meeting, review and determine whether to approve such Device Program Plan, either in the form provided by the JDC or with such modifications or amendments agreed upon by the JSC. If the JSC approves such Device Program Plan (with any modifications or amendments agreed upon by the JSC), such Device Program Plan shall be incorporated in the Development Plan. If the JSC fails to approve the Device Program Plan in accordance with Section 2.5, then (1) for the Co-Commercialization Territory, neither Party may, directly or indirectly, itself or through any Affiliate or Third Party, Develop or Commercialize the applicable Administration Device for the Co-Commercialization Territory and (2) for the Roche Territory, Roche may, at its sole cost and expense, Develop the applicable Administration Device for the administration of a Product Developed for use in the Field pursuant to the Development Plan for use solely in the Roche Territory.
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Related to Device Program Plans

  • In-Service Programs The parties to this collective agreement recognize the value of in-service education both to the employee and the Employer. A) The Employer reserves the right to identify specific in-service programs deemed compulsory. B) Employees required to attend such programs will be paid at the applicable rate of pay.

  • Development Plans Shipper has provided Gatherer with a report attached hereto as Exhibit D (the “Current Development Plan”) describing in detail, as of January 1, 2017, the planned development, drilling, and production activities to take place with respect to Dedicated Production for the applicable Development Period. The information contained in the TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). Current Development Plan is broken out on a Subsystem-by-Subsystem basis and, with respect to the first three Years covered by the Current Development Plan, on a Quarter-by-Quarter basis, and with respect to the remaining Years covered by the Current Development Plan, on a Year-by-Year basis. The Current Development Plan attached hereto has been approved by the Parties. (a) From time to time during each Year of the Term, the Parties shall meet to discuss the planned development, drilling, and production activities that Shipper expects to take place with respect to Dedicated Production for the then-applicable Development Period. Shipper and Gatherer shall each make their respective representatives available to participate in such meetings and discussions. No later than August 1 of each such Year, Shipper shall provide (or cause to be provided) to Gatherer a proposed update of the then-currently agreed Development Plan, prepared on the same basis as the Current Development Plan and describing in detail the planned development, drilling, and production activities to take place with respect to Dedicated Production for the then-applicable Development Period (any such update, an “Updated Development Plan” and, together with the Current Development Plan, each, a “Development Plan”). Notwithstanding anything herein to the contrary, in no event shall Gatherer be required to agree to any Updated Development Plan and corresponding updated Gathering System Plan that contains a Committed Build-Out that (i) has a corresponding Target Completion Date that occurs after the end of the Initial Term, and (ii) Gatherer, in its sole discretion, does not wish to approve. (b) Each proposed Development Plan shall include information as to the following, in each case, broken out on a Subsystem-by-Subsystem basis and, with respect to the first three Years covered by such Development Plan, on a Quarter-by-Quarter basis, and, with respect to the remaining Years covered by such Development Plan, on a Year-by-Year basis: (i) all Xxxxx that, as of the date such Development Plan was delivered, are currently in existence and (A) the production therefrom is being delivered into the Gathering System, or (B) are awaiting connection to the Gathering System; (ii) the Xxxxx that are expected to be drilled during the time period covered by such Development Plan (each such Well reflected in such Development Plan, a “Planned Well”), and the estimated timing of the drilling of such Planned Xxxxx; (iii) forward-looking production estimates for the applicable time period covered by such Development Plan for all Shipper Gas (A) that Shipper reasonably and in good faith believes will become owned or Controlled by Shipper during the time period covered by such Development Plan, and/or (B) that will be produced from (I) in the aggregate, all Xxxxx then-existing and (II) in the aggregate, any Planned Xxxxx included in such Development Plan (such collective estimates described in subsections (A) and (B), both with respect to a particular Quarter and an entire Year, the “Dedicated Production Estimates”); TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). (iv) forward-looking estimates for the applicable time period covered by such Development Plan of the aggregate volumes of those Shipper Injected Liquids that Shipper intends to Tender to the Injection Points hereunder to receive the System Services (such estimates, both with respect to a particular Quarter and an entire Year, the “System Liquids Estimates” and, together with the Dedicated Production Estimates, the “System Production Estimates”); (v) (A) each new receipt point (including the location thereof) proposed by Shipper with respect to the System Production Estimate reflected in such Development Plan (each such receipt point, including those located at the site of a Planned Well, a “Planned Receipt Point”), (B) each Receipt Point at which Shipper expects to Tender Shipper Gas and/or Shipper Injected Liquids reflected in such Development Plan into the Gathering System, and (C) the estimated portion of the System Production Estimate contained in such Development Plan that Shipper expects to Tender at each such Receipt Point and Planned Receipt Point; (vi) the earliest date on which each Planned Well included in the Development Plan is estimated to be completed and producing, which date shall not be earlier than three Months after the January 1st that is immediately subsequent to the date that the Development Plan that initially reflected such Planned Well was delivered to Gatherer hereunder; (vii) the anticipated characteristics of the production from the Xxxxx and Planned Xxxxx reflected in such Development Plan (including liquids content and gas and liquids composition) and the projected production volumes and production pressures applicable thereto; provided that Shipper may utilize the existing and historical production information from similarly situated Xxxxx; (viii) (A) each new delivery point (including the location thereof) proposed by Shipper with respect to the System Production Estimate reflected in such Development Plan (each such delivery point, a “Planned Delivery Point”), (B) each Delivery Point at which Shipper expects Shipper Gas produced from the Xxxxx and Planned Xxxxx reflected in such Development Plan to be redelivered to Shipper, (C) each Delivery Point at which Shipper expects any Drip Liquids allocated to Shipper in accordance with this Agreement and/or Shipper Injected Liquids to be redelivered to Shipper, and (D) the estimated portion of the System Production Estimate contained in such Development Plan that Shipper expects to be redelivered to Shipper at each such Delivery Point and Planned Delivery Point; (ix) any (A) proposed revision to the then-existing Dedicated Area and/or any then-existing Dedicated Contract and/or (B) any new contract that Shipper proposes to be a Dedicated Contract; and (x) other information reasonably requested by Gatherer that is relevant to the design, construction, and operation of the Gathering System, including (A) any Subsystem Extension proposed by Shipper, (B) the relevant Receipt Point, Planned Receipt Point, Delivery Point and Planned Delivery Point facilities applicable to such TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH TWO ASTERISKS (**). Development Plan, and (C) any treating, processing, or liquids handling facilities proposed by Shipper that may be required for any Shipper Gas and/or Shipper Injected Liquids to meet applicable Downstream Facility specifications at the Delivery Points.

  • Marketing Plans Contractor and the Exchange recognize that Enrollees and other health care consumers benefit from efforts relating to outreach activities designed to increase heath awareness and encourage enrollment. The parties shall share marketing plans on an annual basis and with respect to periodic updates of material changes. The marketing plans of each of the Exchange and Contractor shall include proposed marketing approaches and channels and shall provide samples of any planned marketing materials and related collateral as well as planned, and when completed, expenses for the marketing budget. The Contractor shall include this information for both the Exchange and the outside individual market. The Exchange shall treat all marketing information provided under this Section as confidential information and the obligation of the Exchange to maintain confidentiality of this information shall survive termination or expiration of this Agreement.

  • Service Plans 2.1 Standard Price Service Standard Price Term Home Basic Broadband 100 HK$168 Monthly Plan 24 consecutive months HomeFibre 500 HK$178 Monthly Plan 24 consecutive months HomeFibre 1000 HK$198 Monthly Plan 24 consecutive months a) WiFi service is only applicable at the Company’s designated wireless hotspots, for details, please visit www. xxxxxxxx.xxx b) No first time installation fee required. 2.2 Switch-in Offer a) Customer who accepts Switch-in Offer is entitled to up to 6 free service months provided the total Term will be (i) number of free service months; plus (ii) 24 months For example, if a customer opts in for 6 free service months, the total Term will be 30 months (6 free service months + 24 months = 30 months in total). The free months will be on 25th, 26th, 27th, 28th, 29th, 30th months of the Term. b) The monthly service fee waiver cannot be returned or exchanged for cash. c) The Company may request the Customer to present his existing broadband service contracts or bills with the other operator as verification. d) The Company has the final decision on the number of free service months to be offered. 2.3 Super Value Price a) Super Value Price is calculated based on Standard Price minus the cash bonus for the respective service plans. The cash bonus for Home Basic Broadband 100, HomeFibre 500 and HomeFibre 1000 is $20/month respectively. b) The cash bonus will be credited to the monthly bill of the Customer’s Account. The first Credit Amount will be credited to the 1st monthly bill after the service effective date. c) The Super Value Price service plan is subject to change from time to time. d) Customer who has registered for the Service and simultaneously subscribed to a designated monthly plan for the Company’s mobile telephone services (“Monthly Mobile Plan”) or HomePhone+ (“HomePhone+”) will be eligible for the Super Value Price in place of the Standard Price for the Term subject to the following conditions. e) The Service and the designated Mobile Monthly Plan should be registered under the same name and account; for HomePhone+, the Service and the HomePhone+ should be registered with same HKID. Otherwise the Customer will not be entitled to the Super Value Price. f) The Super Value Price will apply according to the bill date of the Service provided that the designated Mobile Monthly Plan or HomePhone+ is active. Cash bonus will be credited to the monthly bill. If the designated Mobile Monthly Plan or HomePhone+ is terminated/disconnected for whatsoever reason on the bill date of the Service, the Super Value Price of that month will not apply and the Customer will be charged the Standard Price. The Company will check the account status of the designated Mobile Monthly Plan or HomePhone+ on every bill date of the Service to determine whether Super Value Price or the Standard Price will be charged for the Service to the Customer. g) One designated Mobile Monthly Plan or HomePhone+ is entitled to one Super Value Price in a bill month. h) If the Customer subscribes to two Services and one designated Mobile Monthly Plan or HomePhone+, only the Super Value Price with the higher amount will be given to the Customer. i) For customer who has enjoyed the Switch-in Offer, the cash bonus (as described in Clause 2.3(a)) will take effect after the end of the free service months. 2.4 The Customer can change to a higher service plan during the Term and contract period shall remain the same. Customer who change to a lower value service plan is required to pay liquidated damages (as described in Clause 7 below) and also sign a new fixed term contract for the service plan. In both cases, the Customer shall pay an installation fee (if applicable) at the Company’s prevailing rate of charges for the Service from time to time. 2.5 The Service Plan is charged on a monthly basis. The monthly charges for the first month will be charged on a non pro-rata basis from the service effective date to the first bill date. The monthly charges are payable in advance and non-refundable under whatever circumstances. 2.6 Unless otherwise specified by the Customer, the Service will continue to be provided to the Customer after the expiry of the Term and such service will be charged at the same Monthly Service Plan that is chargeable to the Customer on the expiry date of the Term. 2.7 Free Three Months Offer a) This offer is only applicable to Home Basic Broadband 100. b) The offer can be used in conjunction with Switch-in Offer described in Clause 2.2. c) The free service months of this offer are 3rd, 6th, 9th month after the free months of the Switch-in Offer. For example, if a customer opts in for 6 free service months, the total Term will be 30 months (6 free service months + 24 months = 30 months in total). All the free months will be on 3rd, 6th, 9th, 25th, 26th, 27th, 28th, 29th, 30thmonths of the Term. d) No cash bonus will be credited on the free service months. e) All monthly service fee waivers are not transferable and exchangeable for cash. f) The offer is subject to change from time to time.

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular: (a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory; (b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory; (c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization; (e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any; (f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product; (g) discuss Product list price and status of reimbursement in the Collaborator Territory; and (h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.

  • E-Verify Program Grantee certifies that it utilizes and will continue to utilize the U.S. Department of Homeland Security's E-Verify system to determine the eligibility of: A. all persons employed to perform duties within Texas during the term of the Grant Agreement; and B. all persons, (including subcontractors) assigned by the Grantee to perform work pursuant to the Grant Agreement within the United States of America.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Concession Area, including its abandonment.

  • First Source Hiring Program Contractor must comply with all of the provisions of the First Source Hiring Program, Chapter 83 of the San Francisco Administrative Code, that apply to this Agreement, and Contractor is subject to the enforcement and penalty provisions in Chapter 83.

  • Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

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