Commercialization and Supply Sample Clauses

Commercialization and Supply. 4.1 BMPI shall have the exclusive right to distribute and sell the Commercial Products in the Territory during the Term of this Agreement and any Post Term Supply period as described in Section 2.1. Except as provided in Section 14.4, KNC shall be the exclusive manufacturer and supplier of the Products in the Territory during the Term of this Agreement. 4.2 The parties acknowledge that KNC maintains a biomaterials business and supplies products to companies that manufacture and/or develop products that may compete with the Commercial Products. The parties acknowledge that BMPI maintains a broad regenerative medicine business and performs work with suppliers of other biomaterials based products that may compete with the Products or Commercial Products. Subject to the limitations on use of the joint Intellectual Property set forth in Article 8 and exclusive rights set forth in Section 4.1 herein, nothing in this Agreement shall preclude KNC or BMPI from continuing to conduct such business during the Term of this Agreement, or thereafter. 4.3 BMPI may use Distributors in the commercialization of the Commercial Products, provided that BMPI shall be responsible for monitoring such Distributors, so that the terms of this Agreement are met. 4.4 KNC agrees to: a. use best efforts to ensure that the Product will be manufactured, packaged, labeled, and stored in accordance with the QSR. b. use commercially reasonable best efforts to supply BMPI with BMPIs projected Rolling Forecast requirements (pursuant to Subsection 4.5(e)) of Product; c. use commercially reasonable best efforts to deliver Product hereunder on the scheduled delivery dates as set forth in the relevant Purchase Orders described in Section 5.3; provided, however, it will not be considered a breach of this Agreement if at least 85% of a delivery which conforms to Product Specifications is made within sixty (60) days following the date originally agreed upon for delivery. Any shortage greater than ten percent (10%) made against an accepted Purchase Order will be delivered as soon as is practicable. d. supply BMPI with Product manufactured in material compliance with QSR's; e. obtain written approval from BMPI prior to implementing any changes to the Product manufacturing process, raw materials, testing, systems, equipment, procedures, software, or facilities if Section 4.4(j) herein is invoked, otherwise written approval shall be requested for changes which, in KNC's reasonable judgment may impact safe...
Sample 1
AutoNDA by SimpleDocs
Commercialization and Supply. (A) To avoid a disruption in the supply of Licensed Products to patients in the Territory, if this Agreement is terminated after EQRx’s First Commercial Sale in the EQRx Territory, then to the extent requested by Xxxx, EQRx and its Affiliates and Sublicensees shall continue to distribute (but shall not be obligated to market or promote) the Licensed Product in each country of the EQRx Territory for which Regulatory Approval therefor has been obtained, in accordance with the terms and conditions of this Agreement, until the date on which Xxxx notifies EQRx in writing that Xxxx has secured an alternative distributor or licensee for such Licensed Products in the EQRx Territory, but in no event for [***] (the “Wind-down Period”); provided that EQRx, its Affiliates and Sublicensees shall cease such activities, or any portion thereof, upon [***] notice by Xxxx requesting that such activities (or portion thereof) be ceased. Notwithstanding any other provision of this Agreement, during the Wind-down Period, EQRx’s and its Affiliates’ and non-Affiliate Sublicensees’ rights with respect to Licensed Compounds and Licensed Products in the EQRx Territory shall be non-exclusive and Xxxx shall have the right to engage [***] other distributor(s) and/or licensee(s) of a Licensed Compound and Licensed Products in the EQRx Territory. Any Licensed Products sold by EQRx, its Affiliates and/or Sublicensees, in the EQRx Territory during the Wind-down Period shall be subject to royalties and milestone payments under Section 6.3 and Section 6.4. The obligations set forth in this Section 11.5(a)(iv) shall not apply in any country or jurisdiction in which, as of the effective date of termination of this Agreement, the Royalty Term with respect to the applicable Licensed Product has expired or in which a Generic Product is on the market. Within [***] of expiration of the Wind-down Period, EQRx shall notify Xxxx of any quantity of Licensed Compounds and/or Licensed Products remaining in EQRx’s inventory and Xxxx shall have the option, upon notice to EQRx, to repurchase any such quantities of Licensed Compounds and/or Licensed Products, as applicable, from EQRx at a price [***], as applicable.
Sample 1
Commercialization and Supply. 4.1 During the Term of this Agreement, Orthovita shall engage KNC as the exclusive manufacturer, subject to Section 4.2, of one hundred percent (100%) of its Initial Product requirements, including, without limitation, Initial Products required for engineering, testing and clinical trials, if any. That is, except as expressly set forth herein, Orthovita agrees to obtain or, in the case of Commercial Product, purchase all of its Initial Product requirements exclusively from KNC and from no other third party manufacturer. 4.2 If KNC is unable to supply Commercial Product pursuant to Section 4.5(b), Orthovita shall have the right to engage a back-up supplier to manufacture and supply its Commercial Product and to terminate any Purchase Order, in whole or in part, that KNC was unable to fill without liability or charge. Such right shall continue for a period of sixty (60) days after KNC notifies Orthovita that it is prepared to supply all of Orthovita’s Initial Product requirements, as provided herein. 4.3 Notwithstanding the provisions of Section 4.1, the parties acknowledge that KNC maintains a biomaterials business and supplies products to companies that manufacture and/or develop products that may compete with the Initial Products and the Additional Products. Subject to the use of the joint Intellectual Property set forth in Section 8.4 herein, nothing in this Agreement shall preclude KNC from continuing to conduct such business during the Term of this Agreement, or otherwise. 4.4 Orthovita may use Distributors in the commercialization of the Initial Products, provided that, Orthovita shall be responsible for monitoring such Distributors, so that the terms of this Agreement are met.
Sample 1
Commercialization and Supply. Xxxx shall have the exclusive right, even as to Corium, to Commercialize the Product in the Territory. Subject to Section 13.6, Corium shall have the exclusive right, even as to Xxxx, to Commercialize the Product outside of the Territory subject to the terms and conditions of this Agreement and Corium’s royalty obligations under Section 5.1 hereof. Upon final approval by the FDA for the ANDA for the Product and as soon as practicable after the Product may be manufactured and sold in the Territory free from any and all restrictions, as determined by Xxxx in its sole and exclusive discretion, Xxxx shall use commercially reasonable efforts to Commercialize the Product in the Territory. Xxxx shall have the sole and exclusive right to establish and control the prices and all other terms and conditions for the sales of the Product in the Territory. *Confidential Treatment Requested.
Sample 1
Commercialization and Supply 
Sample 1Sample 2Sample 3See All (5)

Related to Commercialization and Supply

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • 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 [***].

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • 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.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • 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.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!