COSTS AND PAYMENT SCHEDULE. Abbott's costs for carrying out the programme of work set out in thix Xxxxxxle B-4 will be US$ [**] made up of: ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. - Manufacture and supply of two batches each of [**] kg Bulk Product US$ [**] - Process analysis (Section 2.2.2) US$ [**] - Development and validation of HPLC method (Section 2.2.3) US$ [**] - Evaluation of microscopy methods (Section 2.2.4) US$ [**] - Evaluation of other methods (Section 2.2.5) US$ [**] Payments will be made by Barrier to Abbott as follows: - US$ [**] within 30 days of signature of this Schedule B-4, and - US$ [**] Barrier's receipt of Abbott's report. ABBOTT GMBH & CO. KG BARRIER XXXXXXXXTICS, INC. Xx: /s/ Jorg Breitenbach By: /s/ Geert Cauwenbergh ---------------------------------- ----------------------------------- Dr. Jorg Breitenbach Head of SOLIQS By: /s/ Jon Lewis Xxxe: 24/04/03 ---------------------------------- -------------------------------- Dr. Jon Lewis Head of Business Development SOLIQS Date: 24tx Xxxxx 0003 -------------------------------- ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. ATTACHMENT TO DEVELOPMENT AND SUPPLY AGREEMENT BETWEEN ABBOTT GMBH & CO. KG AND BARRIER THERAPEUTICS, INC. SCHEDULE B-5 DEVELOPMENT AND PREPARATION OF REGISTRATION BATCHES (STAGES 5 AND 6)
1. AIM OF WORK As a result of the pilot biostudy carried out by Barrier using Bulk Product supplied by Abbott according to Schedule B-2, Barrier now wishes Abbott to perform the necessary additional pharmaceutical development programme and manufacture of six (6) batches each of [**] kg Bulk Product to be used for a pivotal study and for long-term stability testing prior to submission by Barrier of an NDA for Finished Product. The technical responsibilities are described hereunder.
COSTS AND PAYMENT SCHEDULE. In consideration for ICON’s Services under this Project Contract, NTI agrees to pay ICON in accordance with the budget set forth in the attached Exhibit B and incorporated herein by reference. The total amount payable by NTI to ICON in respect of professional fees, exclusive of pass-through expenses, under this Project Contract for direct labor costs shall in no way exceed [***] without prior written consent of both parties. Pass-through expenses under this Project Contract are estimated to be [***].
COSTS AND PAYMENT SCHEDULE. In consideration of the Project performed by Enumeral, Novartis agrees to pay to Enumeral a fee in the amount of * according to the payment schedule outlined below plus VAT if applicable.
COSTS AND PAYMENT SCHEDULE. Abbott's costs for carrying out the programme of work set out in thix Xxxxxxle B-3 will be US$ [**] make up of: - Manufacture and supply of manufacture [**] kg Bulk Product US $ [**] - Process analysis US $ [**] Payments will be made to Abbott by Barrier as follows: - US$[**] within 30 days of signature of this Schedule B-3, - US$[**] on Barrier's receipt of the report. ABBOTT GMBH & CO. KG BARRIER THERAPEUTICS, INC. Xx: /s/ Jorg Breitenbach By: /s/ Charles T. Nomides ---------------------------------- ---------------------------------- Dr. Jorg Breitenbach Charles T. Nomides Xxxx xx XXXXXX XXX Xx: /x/ Xxx Xewis Date: 11-MAR-03 ---------------------------------- -------------------------------- Dr. Jon Lewis Head of Business Development SOLIQS Date: 18 Xxxxx 0003 --------------------------------- ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. ATTACHMENT TO DEVELOPMENT AND SUPPLY AGREEMENT BETWEEN ABBOTT GMBH & CO. KG AND BARRIER THERAPEUTICS, INC. SCHEDULE B-4 PRE-STAGE 5 WORKPLAN 1. AIM OF WORK Abbott will manufacture two batches of [**] kg Bulk Product to be used for technical and analytical assessment and further manufacturing trials. The target of these trials is to [**]. Analytical testing will be carried out with the intention of defining methods of distinguishing between different batches of Bulk Product. The technical responsibilities will be described hereinafter.
COSTS AND PAYMENT SCHEDULE. In consideration for ICON’s Services under this Project Contract, NTI agrees to pay ICON in accordance with the budget set forth in the attached Exhibit B and incorporated herein by reference. The total amount payable by NTI to ICON in respect of professional fees, exclusive of pass-through expenses, under this Project Contract for direct labor costs shall in no way exceed Eight Hundred Twenty-one Thousand One Hundred Forty dollars ($821,140.00) without prior written consent of both parties. Pass-through expenses under this Project Contract are estimated to be Six Thousand Two Hundred Fifty dollars ($6,250).
COSTS AND PAYMENT SCHEDULE. In consideration of the proper performance of the Study by the Institution and the Principal Investigator under the terms of this Agreement, payment will be made by Medpace or its designee to the payee (“Payee”) designated in Schedule A appended hereto as an integral part and incorporated herein by reference. Institution and Principal Investigator will accept payment corresponding to a amounts described in Schedule A from Medpace, or its designee, to the Payee as full consideration for services rendered. All costs outlined on Schedule A shall remain firm for the duration of the Study, unless otherwise agreed to in writing by the Parties. It is understood and agreed that no reimbursement will be provided by Medpace or Sponsor for subjects who are randomized into the Study in violation of the Protocol, or who do not conform to the Protocol’s inclusion and exclusion criteria or for whom serious deviations from the Protocol are made. The budget contained in Schedule A is inclusive of all applicable taxes. VAT is not applicable because Medpace, Inc. is a U.S.-based corporation. Should any changes to VAT law occur during the term of this Agreement or other tax laws require withholding, the party legally responsible shall be liable for VAT or withholdings. Medpace, as Sponsor’s payment agent, shall make payment to Payee under this Agreement from funds escrowed by Sponsor. Notwithstanding the foregoing, Medpace may issue a written amendment, signed only by Medpace, for the purpose of increasing the Study costs as described in the Schedule A. 6 NÁKLADY A ROZVRH PLATEB Jako odměna v souvislosti s řádným prováděním studie ze strany zdravotnického zařízení a hlavního zkoušejícího podle podmínek této smlouvy bude společností Medpace nebo jejím pověřeným zástupcem provedena úhrada příjemci platby (xxxx xxx „příjemce platby“) označenému v příloze A připojené k této smlouvě jako její nedílná součást, a začleněné do ní odkazem. Zdravotnické zařízení a hlavní zkoušející úhradu od společnosti Medpace, či jí pověřeného zástupce odpovídající částkám popsaným v příloze A přijmou jako plnou úhradu za poskytnuté služby. Všechny náklady uvedené v příloze A zůstanou neměnné po celou dobu trvání studie, pokud se smluvní strany písemně nedohodnou jinak. Smluvní strany jsou si vědomy a souhlasí s xxx, že za subjekty, které byly randomizovány do studie v rozporu s protokolem, které nesplňují kritéria protokolu pro zařazení a vyřazení nebo u nich dojde v jejich případě k závažným odchyl...
COSTS AND PAYMENT SCHEDULE. In consideration of the proper performance of the Study by the Institution and the Principal Investigator under the terms of this Agreement and upon approval of Sponsor, payment will be made by Medpace or its designee to the payee (“Payee”) designated in Schedule A-Institution and in Schedule A-Principal Investigator appended hereto and incorporated herein by reference. Institution and Principal Investigator will accept payment from Medpace, or its designee, to the Payee as full consideration for services rendered. All costs outlined on Schedule A-Institution / Schedule A-Principal Investigator shall remain firm for the duration of the Study, unless otherwise agreed to in writing by the Institution and Medpace. It is understood and agreed that no reimbursement will be provided by Medpace or Sponsor for subjects who are randomized into the Study in violation of the Protocol, or who do not conform to the Protocol’s inclusion and exclusion criteria or for whom serious deviations from the Protocol are made. The budget contained in Schedule A-Institution / Schedule A-Principal Investigator is inclusive of all applicable taxes. VAT is not applicable because Medpace is a U.S.-based company. Should any changes to VAT law occur during the term of this Agreement or other tax laws require withholding, the party legally responsible shall be liable for VAT or withholdings. Insert for non- EU countries: Should any tax laws require withholding, the party legally responsible shall be liable for withholdings. Medpace, as Sponsor’s payment agent, shall make payment to Payee under this Agreement from funds provided by Sponsor. Notwithstanding the foregoing, Medpace may issue a written amendment, signed only by Medpace, for the purpose of increasing the Study costs as described in the Schedule A-Institution / Schedule A-Principal Investigator. 6
COSTS AND PAYMENT SCHEDULE. A. All costs and rates outlined in a Work Order shall remain firm for the duration of the Work Order, unless otherwise agreed to in writing by CLINIMETRICS and CLIENT.
B. CLIENT shall make payments to CLINIMETRICS within thirty (30) days of receipt of an invoice from CLINIMETRICS detailing in sufficient detail the Services performed and expenses incurred. Payment shall be in US dollars and directed to: Clinimetrics Research Associates, Inc., *Material has been omitted pursuant to a request for confidential treatment, and such material has been filed separately with the SEC. 0000 Xxxxx Xxxxx Xxxxxx, Xxxxx 000 Xxx Xxxx, XX 00000 ATTN: Chief Financial Officer
C. If payment to CLINIMETRICS is not received within thirty (30) days of receipt of an invoice by CLIENT, CLINIMETRICS will charge CLIENT monthly interest in the amount of 1.5% of the invoice.
D. CLINIMETRICS may not increase the fees and costs charged to CLIENT under this Agreement in any particular Work Order without the prior written consent of CLIENT.
COSTS AND PAYMENT SCHEDULE. In consideration of the proper performance of the Study by the Institution and the Investigator under the terms of this Agreement and upon approval of Sponsor, payment will be made by Medpace or its designee on behalf of Sponsor to the payee (“Payee”) designated in Schedule A appended hereto and incorporated herein by reference. Payee will accept payment from Medpace, or its designee, to the Payee as full consideration for services rendered. All costs outlined on Schedule A are inclusive of all direct, indirect, overhead and other costs, including laboratory and ancillary service charges, and shall remain firm for the duration of the Study, unless otherwise agreed to in writing by the Parties. It is understood and agreed that no reimbursement will be provided by Medpace or Sponsor for subjects who are randomized into the Study in violation of the Protocol, or who do not conform to the Protocol’s inclusion and exclusion zadavatele o jakýchkoli inspekcích státních či regulačních orgánů (jako například etické komise nebo SUKLu), o nichž se v souvislosti se studií dozví, před konáním takové inspekce.. Zdravotnické zařízení a hlavní zkoušející budou plně spolupracovat při inspekcích prováděných FDA nebo jiným vládním nebo regulačním orgánem. Společnost Medpace a zadavatel xxxx právo zúčastnit se jakýchkoli takových inspekcí a dostanou příležitost poskytnout, posoudit a připomínkovat jakékoli odpovědi, které mohou být nezbytné. Zdravotnické zařízení nebo zkoušející xxxx společnosti Medpace a zadavateli poskytnou kopie všech materiálů, korespondence, prohlášení, formulářů a záznamů, které zdravotnické zařízení a/nebo zkoušející v souvislosti s takovou inspekcí nebo auditem obdrží nebo získají. 7 NÁKLADYAROZVRHPLATEB Jako odměna v souvislosti s řádným prováděním studie ze strany zdravotnického zařízení a zkoušejícího podle podmínek této smlouvy a po schválení zadavatelem bude společností Medpace nebo pověřeným zástupcem zadavatele provedena úhrada příjemci platby (xxxx xxx „příjemce platby“) označenému v příloze A připojené k této smlouvě a začleněné do ní odkazem. Příjemce platby od společnosti Medpace či xx xxxxxxxx osoby přijme úhradu ve prospěch příjemce platby jako plnou kompenzaci za poskytnuté služby. Všechny částky uvedené v příloze A zahrnují veškeré přímé, nepřímé, režijní a jiné náklady, včetně poplatků laboratoři a za dodatečné služby, a po dobu trvání studie zůstanou fixní, pokud se strany písemně nedohodnou jinak. Smluvní strany jsou si vědomy a souh...
COSTS AND PAYMENT SCHEDULE. Abbott's costs for carrying out the programme of work set out in thix Xxxxxxle B-5 will be E [**] made up of: - Process development related to manufacture of NDA batches (of which Part A + Part B = E[**]; Part C = E[**]) E[**] - Preparation of NDA documentation E[**] - Manufacture of six NDA batches E[**] - Process analysis E[**] - Development report E[**] Payments will be made by Barrier to Abbott as follows: - E[**] within 30 days of signature of this Schedule B-5; - E[**] on supply by Abbott of sixth NDA batch; - Milestone payment of US$[**] on Barrier's, or its nominee's, receipt of the sixth NDA batch; - E[**] on Barrier's receipt of Abbott's development report; - E[**] on completion by Abbott of prxxxxx xxvelopment Part C. ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. ABBOTT GMBH & CO. KG BARRIER THERAPEUTIXX, XXC. By: ppa /s/ Jorg Breitenbach By: /s/ Charles T. Nomides ---------------------------------- ------------------------ Dr. Jorg Breitenbach Director, Head of SOLIQS
