Common use of Product Registration Clause in Contracts

Product Registration. 8.1 It is acknowledged by both parties hereto that the import and distribution of Product in the Territory may be dependent upon prior registration of such Product with the appropriate local government authority in the Territory. DISTRIBUTOR shall investigate and so advise OWNER in this regard and, should Product registration or other market authorization be required to import and sell Product in the Territory, DISTRIBUTOR acknowledges and agrees that it shall be responsible for securing the registration of the Product or other market authorization, as the case may be, for, and on behalf of, and in the name of, OWNER. 8.2 In furtherance of the foregoing, DISTRIBUTOR agrees to use its best efforts to arrange for and complete the registration of the Product in OWNER’s name in a timely manner, which in any event must occur within ninety (90) days of the Effective Date of this Agreement. DISTRIBUTOR shall pay all costs relating to such registration of Product, in accordance with all applicable laws, rules and regulations of the Territory and shall indemnify and save harmless OWNER in respect to the same. DISTRIBUTOR shall keep OWNER informed in writing of the progress of any required application for registration, and any proposed submissions relating to such Product registration must be forwarded to OWNER for its approval prior to being submitted to the appropriate government authority. Thereafter, upon registration of the Product, DISTRIBUTOR will inform OWNER and provide copies and official government receipts in respect thereto. Upon receiving the official registration documents and the receipts evidencing payment in full for such registration by DISTRIBUTOR, in OWNER’s name, OWNER will reimburse DISTRIBUTOR for the cost of such Product registration. DISTRIBUTOR agrees that it will be responsible for the cost of any Product registration that is submitted without the prior approval of OWNER. 8.3 OWNER shall retain title to all Product registrations and Trademarks. 8.4 To the extent that Product registration has been affected in the name of DISTRIBUTOR, DISTRIBUTOR will co-operate fully in the transfer of such registrations to OWNER or any Person designated by OWNER.

Product Registration. 8.1 It is acknowledged by both parties hereto that 5.1 Biocon shall, at its expense, register the import and distribution of Product in the Territory may be dependent upon prior registration of such Product Products with the appropriate local government authority governmental agency(s) in the Territory, reflecting CytoSorbents as the manufacturer of the Product and the Biocon as the marketing authorization holder. The Biocon shall not, without written permission from CytoSorbents, undertake any such Product registration in any other name including in Biocon's own name, provided that such registration complies with the technical and legal requirements in the Territories and provided further that Biocon may be the marketing authorization holder in the Territory. DISTRIBUTOR Biocon shall investigate submit all necessary applicable regulatory applications for registering the Product as follows: (a) within the India Territory no later than two (2) months after the Effective Date, and so advise OWNER (b) within the Sri Lanka Territory no later than six (6) months after the Effective Date, subject to CytoSorbents providing Biocon the documents described in this regard andAnnex 8 at least three (3) months prior to regulatory application. Biocon shall deliver to CytoSorbents copies of all such proposed applications prior to the Biocon filing such applications with the applicable regulatory authority. CytoSorbents shall have the right to comment on such applications. If such comments are received before filing, should then Biocon shall modify such applications based on such comments. CytoSorbents shall assist in obtaining such registrations and give Biocon power of attorney for purposes of registration and shall provide reasonably necessary technical support to Biocon to meet all applicable regulatory requirements in the Territory. If the applicable regulatory agency in the Sri Lanka Territory requires that additional human clinical trials of the Product registration or other market authorization be required to import and sell conducted before granting marketing approval for sale of the Product in the Sri Lanka Territory, DISTRIBUTOR acknowledges then the Parties shall discuss in good faith whether to amend this Agreement to delete Sri Lanka from the Territory and agrees substitute another country or region that it will not require additional human clinical trials of the Product. 5.2 Biocon shall be responsible for securing maintaining adequate lot traceability to assure recall of Products, if necessary, as detailed in Section 10.1.2.3. 5.3 Upon expiration and termination for any reason of this Agreement Biocon shall, at CytoSorbents' option and at the registration sole expense of CytoSorbents, either (a) de-register the Product from all government and regulatory authorities within 30 days, or other market authorization(b) transfer any and all registrations, as import licenses, permits or certificates for the case may be, for, and on behalf of, and in the name of, OWNER. 8.2 In furtherance of the foregoing, DISTRIBUTOR Products to CytoSorbents or CytoSorbents designee within 30 days. Biocon agrees to use its best efforts to arrange for affect such transfer and complete the registration of the Product in OWNER’s name in a timely manner, which in any event must occur within ninety (90) days of the Effective Date of this Agreement. DISTRIBUTOR shall pay all costs relating to such registration of Product, deregistration in accordance with all applicable local laws, rules and regulations . Notwithstanding the foregoing in case of termination of this Agreement by CytoSorbents for breach of the Territory and Agreement by Biocon, Biocon shall indemnify and save harmless OWNER in respect to the same. DISTRIBUTOR shall keep OWNER informed in writing of the progress of any required application for registration, and any proposed submissions relating to such Product registration must be forwarded to OWNER for its approval prior to being submitted to the appropriate government authority. Thereafter, upon registration of the Product, DISTRIBUTOR will inform OWNER and provide copies and official government receipts in respect thereto. Upon receiving the official registration documents and the receipts evidencing payment in full for such registration by DISTRIBUTOR, in OWNER’s name, OWNER will reimburse DISTRIBUTOR for the cost of such Product registration. DISTRIBUTOR agrees that it will be solely responsible for the cost of any Product all de-registration that is submitted without the prior approval of OWNERexpenses. 8.3 OWNER shall retain title to all Product registrations and Trademarks. 8.4 To the extent that Product registration has been affected in the name of DISTRIBUTOR, DISTRIBUTOR will co-operate fully in the transfer of such registrations to OWNER or any Person designated by OWNER.

Product Registration. 8.1 It is acknowledged by both parties hereto that the import 3.1. Yamanouchi shall be responsible, at its sole cost and distribution of Product expense, for (i) submitting all applications in each country in the Territory may be dependent upon prior for registration or approval of such Product the Products with the appropriate local government authority authorities in each country in the Territory requiring such an application; (ii) conducting or having others conduct on its behalf, any clinical trials necessary to support Submission of all such applications for each Product, including, but not limited to all statistical analysis and preparation of any registration summary documents, with the appropriate regulatory authorities in each country within the Territory requiring such an application; (iii) filing and obtaining all such registrations and approvals; and (iv) conducting Market Research in each such country. Yamanouchi shall use its reasonable efforts to make its Submission in each country in the Territory on 18. the Initial Territory Glucose Monitoring Product or any Improved Glucose Monitoring Product included in this Agreement as soon as reasonably possible; PROVIDED, HOWEVER, in the case of the Initial Territory Glucose Monitoring Product, Yamanouchi shall use reasonable efforts to make its Submission no later than an estimated target date set in notice to Cygnus to be provided by Yamanouchi within six (6) months of execution of this Agreement, which date shall be established by Yamanouchi after its consultation with regulatory agencies in the Territory. DISTRIBUTOR shall investigate and so advise OWNER in this regard and, should Product registration or other market authorization be required to import and sell Product in the Territory, DISTRIBUTOR acknowledges and agrees that it shall be responsible for securing the registration of the Product or other market authorization, as the case may be, for, and on behalf of, and in the name of, OWNER. 8.2 In furtherance of the foregoing, DISTRIBUTOR agrees to use its best efforts to arrange for and complete the registration of the Product in OWNER’s name in a timely manner, which in any event must occur within ninety (90) days of the Effective Date of this Agreement. DISTRIBUTOR shall pay all costs relating to such registration of Product, in accordance with all applicable laws, rules and regulations of the Territory and shall indemnify and save harmless OWNER in respect to the same. DISTRIBUTOR shall keep OWNER informed in writing of the progress of any required application for registration, and any proposed submissions relating to such Product registration must be forwarded to OWNER for its approval prior to being submitted to the appropriate government authority. Thereafter, upon registration of the Product, DISTRIBUTOR will inform OWNER and provide copies and official government receipts in respect thereto. Upon receiving the official registration documents and the receipts evidencing payment in full for such registration by DISTRIBUTOR, in OWNER’s name, OWNER will reimburse DISTRIBUTOR for the cost of such Product registration. DISTRIBUTOR agrees that it will be responsible for the cost of any Product registration that is submitted without the prior approval of OWNER. 8.3 OWNER shall retain title to all Product registrations and Trademarks. 8.4 To the extent that Product approval must be obtained or application made for any governmental or insurance reimbursement plan, Yamanouchi shall use reasonable efforts to obtain such reimbursement rate in an amount designed to maximize Total Net Sales, and in no event less than the amount established for existing glucose monitoring products. Yamanouchi shall promptly submit copies of all documentation related to each application and registration has been affected (including regulatory approvals) to Cygnus for its use and review. 3.2. Cygnus shall cooperate with Yamanouchi in Yamanouchi's Submission in the name of DISTRIBUTORcountries within the Territory by providing such materials as may otherwise be in existence and as are necessary to Yamanouchi's Submission. Such materials include the U.S. Regulatory Submissions. In addition, DISTRIBUTOR will coCygnus shall at its cost conduct more than seventeen (17) month real-operate fully time stability tests on the Glucopad in the transfer U.S. pursuant to the regulations issued by the Ministry of such registrations Health and Welfare of Japan ("Koseisho"), which regulations shall be delivered to OWNER or any Person designated Cygnus by OWNER.Yamanouchi after execution hereof upon consultation with Koseisho. (The foregoing covenant with respect to length of

Product Registration. 8.1 It is acknowledged by both parties hereto that the import and distribution of Product in the Territory may be dependent upon prior registration of such Product with the appropriate local government authority in the Territory. DISTRIBUTOR shall investigate and so advise OWNER in this regard and, should Product registration or other market authorization be required to import and sell Product in the Territory, DISTRIBUTOR acknowledges and agrees that it shall be responsible for securing the registration of the Product or other market authorization, as the case may be, for, and on behalf of, and in the name of, OWNER. 8.2 In furtherance of the foregoing, DISTRIBUTOR agrees to use its best efforts to arrange for and complete the registration of the Product in OWNER’s name in a timely manner, which in any event must occur within ninety one hundred and eighty (90180) days of the Effective Date of this Agreement. , or within one hundred and eighty (180) days of the effective date of any amendment to the list of Product in Schedule “A” attached hereto, in the case of additional finished goods products being added thereto, and DISTRIBUTOR shall pay all costs relating to such registration of Product, in accordance with all applicable laws, rules and regulations of the Territory and shall indemnify and save harmless OWNER in respect to the same. DISTRIBUTOR shall keep OWNER informed in writing of the progress of any required application for registration, and any proposed submissions relating to such Product registration must be forwarded to OWNER for its approval prior to being submitted to the appropriate government authority. Thereafter, upon registration of the Product, DISTRIBUTOR will inform OWNER and provide copies and official government receipts in respect thereto. Upon receiving the official registration documents and the receipts evidencing payment in full for such registration by DISTRIBUTOR, in OWNER’s name, OWNER will reimburse DISTRIBUTOR for the cost of such Product registration. DISTRIBUTOR agrees that it will be responsible for the cost of any Product registration that is submitted without the prior approval of OWNER. 8.3 OWNER shall retain title to all Product registrations and TrademarksTrade-marks. 8.4 To the extent that Product registration has been affected effected in the name of DISTRIBUTOR, DISTRIBUTOR will co-operate fully in the transfer of such registrations to OWNER or any Person designated by OWNER.