Nature of the Project. As the Product has never been produced by BII or on behalf of BII by its Affiliated Companies at the BI Facility, XENCOR acknowledges that the Project is experimental in nature and that no favorable or useful results can be assured by BII. However, after […***…], the Parties shall in good faith agree on a revision (if necessary) to the preliminary specifications for the Product (that have been mutually agreed upon by the Parties) that shall then be the Specifications for subsequent runs in subsequent campaigns that shall form a basis for rejection or acceptance of the respective Product produced in any additional runs at such scale under the provisions of Section 4.1, and, provided that the Process has not been materially changed (i.e. a change that is subject to the Change Control procedures of the QAA), the Project shall no longer be considered experimental in nature and the obligation to meet the respective Specification shall apply to all future runs at such scale.
Nature of the Project. By the nature of the Collaboration, Arising Intellectual Property that may arise is difficult to predict, and the Parties consider it desirable to defer settling the terms on which it will be available until the Arising Intellectual Property is known.
Nature of the Project. As the Products have never been produced at the [***] scale, ELAN acknowledges that the Projects are experimental in nature and that no favorable or useful results at such scale can be assured by BI Pharma. However, after [***] initial [***] or [***]-runs ([***]), the Parties shall in good faith agree on a revision (if necessary) to the preliminary specifications based on the outcome of the comparability discussions with the relevant regulatory authorities that shall then be the Specifications for subsequent runs in subsequent campaigns that shall form a basis for rejection or acceptance of the respective Product produced in any additional runs at the [***] or [***] scale under the provisions of Section 4.1, and, provided that the respective Process and the respective Product Hex Cell Line have not been materially changed (i.e. a change that is subject to the Change Control procedures of the QAA) the respective Project shall no longer be considered experimental in nature and the obligation to meet the respective Specification shall apply to all future runs at the [***] or [***] scale.
Nature of the Project. The projec t proposed involves the c onstruc tion of approximately 510 no resid ential housing units with a possib le retail/ c ommerc ia l use of the listed building on site. There will be a mix of 2, 3 and 4 bedroom 2 storey houses. Assoc ia xxx with these house types are a mix of sing le and double garages. The projec t will also inc lude the demolition of 4 no warehouses and anc illa ry buildings inc luding 2 no sub sta tions. The projec t is loc ated at Bra nston Depot, Xxxxxx Xxx d, Xxxxxx upon Xxxxx. The site is c urrently oc c upied by buildings and infra struc ture a ssoc ia xxx with the existing B&Q depot. The site c overs an area of approximately 20.3 hec tares and is situa xxx at the c entre of a triangular sha ped resid ential area whic h is bound to the north ea st and north west by ra ilway lines and to the south by the X0000 Xxxxxx Xxx d. To the south of the site, beyond Xxxxxx Xxx d, lies the un-developed flood plain of the River Trent. Construc tion related works have no sp ec ified sta rt date until planning approval is ac hieved. This projec t has been c ommissioned by Bed ell Corporate Trustees Lim ited and Atrium Trustees Lim ited as joint trustees of the Xxxxxx Xxx d Unit Trust (the c lient), with a c urrently undetermined p arty operating as the princ ipal c ontrac tor. Prior to the development of this Site Wa ste Management Pla n (SWMP) the following stra tegic dec isions will made by the projec t team to ensure that sp ec ific , and overall, projec t generated wa ste will be eliminated or reduc ed at the earliest sta ge: The minimisa tion of wa ste will be c onsid ered during the desig n of the development; Any demolition arising s will be reused in the c onstruc tion of the road s; The arising s from the removal of existing foundations will be c rushed to 6F2 sta ndard, as per Wra p Quality Protoc ol for the produc tion of aggregate from inert wa ste, and re-used throughout the c onstruc tion pha se; The desig n of the ground works using driven piles will result in zero arising s during this pha se of the works; and During c onstruc tion, methods to minimise the wa ste produc ed and the seg regation of wa ste to maximise the opportunities of rec xx xxxx or reuse of all wa stes will be implemented on site.
Nature of the Project. As the Product has never been produced by BI at the Facility, CUSTOMER acknowledges that the Project is experimental in nature and that no favorable or useful Product(s) can be assured by BI. Therefore, the Parties have agreed to the [*] set forth in Appendix 5. The technology transfer phase shall be completed with the first successful manufactured Batch at [*] scale [*] that meets the Product Specifications as mutually agreed by the Parties. Notwithstanding the foregoing, the Parties are in agreement that [*] shall be performed [*]. After [*] initial manufacturing runs [*], the Parties shall in good faith agree on a revision (if necessary) of the preliminary specifications that shall then be the respective Specifications for the Product in the respective clinical Phase manufactured in subsequent manufacturing runs at such scale, and, provided that the Manufacturing Process has not been materially changed the Project shall no longer be considered experimental in nature and the obligation to meet the respective Specification shall apply to all future manufacturing runs at such scale.
Nature of the Project. Gas Purchaser acknowledges and agrees that [Issuer] will meet its obligations to provide Gas supply service to Gas Purchaser under this Agreement through its purchase of long-term Gas supplies on a prepaid basis from the Gas Supplier under the Prepaid Gas Agreement and that [Issuer] is financing its purchase of such long-term supplies through the issuance of the Series 2018 Bonds. Gas Purchaser acknowledges and agrees that [Issuer]will pledge its right, title, and interest under this Agreement and the revenues to be received under this Agreement (other than the revenues attributable to the project administration fee described in Section 4.3) to secure [Issuer]’s obligations under the Indenture.
Nature of the Project. 2.4.1 The Project comprises housing and infrastructure developments at ARQ with a Study Area of about 86 hectares (including a platform site of approximately 40 hectares). The planning of the developments within ARQ are broadly divided into four areas, namely the Civic Core, Northern Community, Southern Community, and Recreation Network, and will provide a mix of housing types as well as basic infrastructure and community facilities for a target population of 25,000.
Nature of the Project. As the Product has never been produced by BI at the Facility, CUSTOMER acknowledges that the Project is experimental in nature and that no favorable or useful Product(s) can be assured by BI. Therefore, the Parties have agreed to the [*] set forth in Appendix 5. [*] = 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 406 of the Securities Act of 1933, as amended.
Nature of the Project. As the Product with the optimized Phase III Manufacturing Process for Drug Substance and the prefilled syringes or vials for Drug Product has never been produced by BI at the Facility, CUSTOMER acknowledges that the Project is experimental in nature and that no favourable or useful Product(s) can be assured by BI. Therefore, the Parties have agreed to [*] as set forth in Appendix 5 of the Agreement. The new technology transfer phase shall be completed with the first successful manufactured Batch at [*] scale (e.g. [*]) that meets the Product Specifications as mutually agreed by the Parties. Notwithstanding the foregoing, the Parties are in agreement that [*] shall be performed [*]. After [*] initial manufacturing runs [*], the Parties shall in good faith agree on a revision (if necessary) of the preliminary specifications that shall then be the respective Specifications for the Product in the respective clinical Phase manufactured in subsequent manufacturing runs at such scale, and, provided that the Manufacturing Process has not been materially changed the Project shall no longer be considered experimental in nature and the obligation to meet the respective Specification shall apply to all future manufacturing runs at such scale".
Nature of the Project. Gas Purchaser acknowledges and agrees that MMGA will meet its obligations to provide Gas supply service to Gas Purchaser under this Agreement through its purchase of long-term Gas supplies on a prepaid basis from the Gas Supplier under the Prepaid Gas Agreement and that MMGA is financing its purchase of such long-term supplies through the issuance of the Series 2019 Bonds. Gas Purchaser acknowledges and agrees that MMGA will pledge its right, title, and interest under this Agreement and the revenues to be received under this Agreement (other than the revenues attributable to the Project Administration Fee described in Section 4.3) to secure MMGA’s obligations under the Indenture.
