Common use of Product Registration Clause in Contracts

Product Registration. 3.1. Yamanouchi shall be responsible, at its sole cost and expense, for (i) submitting all applications in each country in the Territory for registration or approval of the Products with the appropriate 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. To the extent that 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 (including regulatory approvals) to Cygnus for its use and review. 3.2. Cygnus shall cooperate with Yamanouchi in Yamanouchi's Submission in the countries 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, Cygnus shall at its cost conduct more than seventeen (17) month real-time stability tests on the Glucopad in the U.S. pursuant to the regulations issued by the Ministry of Health and Welfare of Japan ("Koseisho"), which regulations shall be delivered to Cygnus by Yamanouchi after execution hereof upon consultation with Koseisho. (The foregoing covenant with respect to length of

Product Registration. 3.1. Yamanouchi shall be responsible, at its sole cost 8.1 It is acknowledged by both parties hereto that the import and expense, for (i) submitting all applications in each country distribution of Product in the Territory for may be dependent upon prior registration or approval of the Products such Product with the appropriate authorities in each country local government authority in the Territory requiring such an application; 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 one hundred and eighty (ii180) conducting days of the Effective Date of this Agreement, or having others conduct on its behalf, any clinical trials necessary to support Submission within one hundred and eighty (180) days of all such applications for each Product, including, but not limited to all statistical analysis and preparation the effective date of any registration summary documents, with amendment to the appropriate regulatory authorities list of Product 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, HOWEVERSchedule “A” attached hereto, in the case of the Initial Territory Glucose Monitoring additional finished goods products being added thereto, and DISTRIBUTOR shall pay all costs relating to such registration of Product, Yamanouchi in accordance with all applicable laws, rules and regulations of the Territory and shall use reasonable efforts indemnify and save harmless OWNER in respect to make 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 Submission no later than an estimated target date set 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 notice 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 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. all Product registrations and Trade-marks. 8.4 To the extent that 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 Product registration (including regulatory approvals) to Cygnus for its use and review. 3.2. Cygnus shall cooperate with Yamanouchi in Yamanouchi's Submission has been effected in the countries 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 additionname of DISTRIBUTOR, Cygnus shall at its cost conduct more than seventeen (17) month realDISTRIBUTOR will co-time stability tests on the Glucopad operate fully in the U.S. pursuant transfer of such registrations to the regulations issued OWNER or any Person designated by the Ministry of Health and Welfare of Japan ("Koseisho"), which regulations shall be delivered to Cygnus by Yamanouchi after execution hereof upon consultation with Koseisho. (The foregoing covenant with respect to length ofOWNER.

Product Registration. 3.1. Yamanouchi shall be responsible5.1 Biocon shall, at its sole cost and expense, for (i) submitting all applications in each country in the Territory for registration or approval of register the Products with the appropriate authorities in each country governmental agency(s) in the Territory requiring 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 an application; (ii) conducting or having others conduct on its behalfProduct registration in any other name including in Biocon's own name, any clinical trials 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. Biocon shall submit all necessary to support Submission of all such applicable regulatory applications for each Product, including, but not limited to all statistical analysis and preparation of any registration summary documents, with registering the appropriate regulatory authorities in each country Product as follows: (a) within the India 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 two (2) months after the Effective Date, and (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 Annex 8 at least three (3) months prior to regulatory application. Biocon shall deliver to CytoSorbents copies of execution 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, then Biocon shall modify such applications based on such comments. CytoSorbents shall assist in obtaining such registrations and give Biocon power of this Agreement, which date attorney for purposes of registration and shall be established by Yamanouchi after its consultation with provide reasonably necessary technical support to Biocon to meet all applicable regulatory agencies requirements in the Territory. To If the extent applicable regulatory agency in the Sri Lanka Territory requires that additional human clinical trials of the Product be conducted before granting marketing approval must for sale of the Product in the Sri Lanka Territory, then the Parties shall discuss in good faith whether to amend this Agreement to delete Sri Lanka from the Territory and substitute another country or region that will not require additional human clinical trials of the Product. 5.2 Biocon shall be obtained or application made responsible for 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 governmental reason of this Agreement Biocon shall, at CytoSorbents' option and at the sole expense of CytoSorbents, either (a) de-register the Product from all government and regulatory authorities within 30 days, or insurance reimbursement plan(b) transfer any and all registrations, Yamanouchi shall use reasonable efforts import licenses, permits or certificates for the Products to obtain CytoSorbents or CytoSorbents designee within 30 days. Biocon agrees to affect such reimbursement rate transfer and deregistration in an amount designed to maximize Total Net Salesaccordance with all applicable local laws. Notwithstanding the foregoing in case of termination of this Agreement by CytoSorbents for breach of the Agreement by Biocon, 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 (including regulatory approvals) to Cygnus for its use and review. 3.2. Cygnus shall cooperate with Yamanouchi in Yamanouchi's Submission in the countries 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, Cygnus shall at its cost conduct more than seventeen (17) month real-time stability tests on the Glucopad in the U.S. pursuant to the regulations issued by the Ministry of Health and Welfare of Japan ("Koseisho"), which regulations Biocon shall be delivered to Cygnus by Yamanouchi after execution hereof upon consultation with Koseisho. (The foregoing covenant with respect to length ofsolely responsible for all de-registration expenses.

Product Registration. 3.1. Yamanouchi shall be responsible, at its sole cost It is acknowledged by both parties hereto that the import and expense, for (i) submitting all applications in each country distribution of Product in the Territory for may be dependent upon prior registration or approval of the Products such Product with the appropriate authorities in each country local government authority in the Territory requiring such an application; 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. 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 one hundred and eighty (ii180) conducting days of the Effective Date of this Agreement, or having others conduct on its behalf, any clinical trials necessary to support Submission within one hundred and eighty (180) days of all such applications for each Product, including, but not limited to all statistical analysis and preparation the effective date of any registration summary documents, with amendment to the appropriate regulatory authorities list of Product 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, HOWEVERSchedule “A” attached hereto, in the case of the Initial Territory Glucose Monitoring additional finished goods products being added thereto, and DISTRIBUTOR shall pay all costs relating to such registration of Product, Yamanouchi in accordance with all applicable laws, rules and regulations of the Territory and shall use reasonable efforts indemnify and save harmless OWNER in respect to make 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 Submission no later than an estimated target date set 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 notice 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. OWNER shall retain title 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 Territoryall Product registrations and Trade-marks. To the extent that 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 Product registration (including regulatory approvals) to Cygnus for its use and review. 3.2. Cygnus shall cooperate with Yamanouchi in Yamanouchi's Submission has been effected in the countries 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 additionname of DISTRIBUTOR, Cygnus shall at its cost conduct more than seventeen (17) month realDISTRIBUTOR will co-time stability tests on the Glucopad operate fully in the U.S. pursuant transfer of such registrations to the regulations issued OWNER or any Person designated by the Ministry of Health and Welfare of Japan ("Koseisho"), which regulations shall be delivered to Cygnus by Yamanouchi after execution hereof upon consultation with Koseisho. (The foregoing covenant with respect to length ofOWNER.