Common use of Registration Procedure Clause in Contracts

Registration Procedure. 7.1 ALVOTECH shall as soon as reasonably possible (within a maximum of [***]) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement with respect to such country, provided that: (a) ALVOTECH has first notified STADA in writing of such non-submission (describing the country and due date of the submission), (b) ALVOTECH granted a last grace period of [***] to rectify such failure, and (c) STADA has not done so within said grace period, except that said [***] period shall be prolonged by such reasonable period which is necessary to allow for any required additional local studies to be conducted. STADA will keep ALVOTECH informed about progress of all such applications. Upon any such termination in a country, the relevant provisions in Article 17.5 shall apply with respect to such country. 7.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than the confidentiality obligations of this Agreement.

Registration Procedure. 7.1 ALVOTECH shall as soon as reasonably possible (within a maximum of [***]] months) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] months after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement with respect to such country, provided that: (a) ALVOTECH has first notified STADA in writing of such non-submission (describing the country and due date of the submission), (b) ALVOTECH granted a last grace period of [***] month to rectify such failure, and (c) STADA has not done so within said grace period, except that said [***] months’ period shall be prolonged by such reasonable period which is necessary to allow for any required additional local studies to be conducted. STADA will keep ALVOTECH informed about progress of all such applications. Upon any such termination in a country, the relevant provisions in Article 17.5 shall apply with respect to such country. 7.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] working days (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] working day from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] working days after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than the confidentiality obligations of this Agreement.

Registration Procedure. 7.1 ALVOTECH shall as soon as reasonably possible (within a maximum of [***]) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement with respect to such country, provided that: (a) ALVOTECH has first notified STADA in writing of such non-submission (describing the country and due date of the submission), (b) ALVOTECH granted a last grace period of [***] to rectify such failure, and (c) STADA has not done so within said grace period, except that said [***] ]’ period shall be prolonged by such reasonable period which is necessary to allow for any required additional local studies to be conducted. STADA will keep ALVOTECH informed about progress of all such applications. Upon any such termination in a country, the relevant provisions in Article 17.5 shall apply with respect to such country. 7.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] working day from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] working days after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than the confidentiality obligations of this Agreement.

Registration Procedure. 7.1 ALVOTECH shall If and whenever GMC is required to use its best ---------------------- efforts to take action pursuant to any Federal or state law or regulation to permit the sale or other disposition of any Unregistered GMC Common Stock that are then held or that may be acquired in connection with the Earn Out Payment, if any, or the exercise of Escrow Warrants in order to effect or cause the registration of any Unregistered GMC Common Stock under the Act as soon provided in Section 1 or 2, GMC shall, as reasonably possible (within a maximum of [***]) after completion expeditiously as practicable: a. furnish to each Selling Stockholder and the underwriters, if any, without charge, as many copies of the Dossier registration statement, the prospectus or prospectuses (including each preliminary prospectus) and STADA’s approvalany amendment or supplement thereto as they may reasonably request; b. enter into such agreements (including an underwriting agreement) and take all other actions reasonably required in connection therewith in order to expedite or facilitate the disposition of such Unregistered GMC Common Stock and in such connection, if the registration is in coordination connection with STADAan underwritten offering (i) make such representations and warranties to the underwriters in such form, submit substance and scope as are customarily made by issuers to EMA a CP for underwriters in underwritten offerings and confirm the Products same if and when requested; (ii) obtain opinions of counsel to GMC and updates thereof (which counsel and opinions in STADA’s name form, scope and substance shall be reasonably satisfactory to the underwriters) addressed to the underwriters and the Selling Stockholders covering the matters customarily covered in opinions requested in underwritten offerings and such other matters as Marketing Authorisation holder may be reasonably requested by such underwriters; (iii) obtain "cold comfort" letters and with STADA’s own brand name/trademark. 7.2 In additionupdates thereof from GMC's accountants addressed to the underwriters, ALVOTECH grants the right such letters to STADA, STADA’s Affiliates be in customary form and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries covering matters of the Territory not type customarily covered in "cold comfort" letters by underwriters and the CP via national procedures. STADA is entitled to decide independently whether Selling Stockholders in connection with underwritten offerings; (iv) set forth in full in any underwriting agreement entered into the indemnification provisions and when to submit for national applications for the Products in such countries to obtain MAs in the name procedures of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement Section 4 with respect to all parties to be indemnified pursuant to Section 4; and (v) deliver such countrydocuments and certificates as may be reasonably requested by the underwriters to evidence compliance with clause (i) of this Section 3(b) and with any customary conditions contained in the underwriting agreement or other agreement entered into by GMC; the above shall be done at each closing under such underwriting or similar agreement or as and to the extent required thereunder; c. make available for inspection by the Stockholders' Representative all financial and other records, provided that: (a) ALVOTECH has first notified STADA pertinent corporate documents and properties of GMC, and cause GMC's officers, directors and employees to supply all information reasonably requested by any such representatives in writing connection with such registration. Similarly, each Selling Stockholder shall furnish to GMC such information regarding the distribution of such non-submission (describing securities and such other information as may otherwise be required by the country and due date of the submission), (b) ALVOTECH granted a last grace period of [***] to rectify such failure, and (c) STADA has not done so within said grace period, except that said [***] period shall be prolonged by such reasonable period which is necessary to allow for any required additional local studies Act to be conducted. STADA will keep ALVOTECH informed about progress of included in the related registration statement. d. otherwise use its best efforts to comply with all applicable Federal and state regulations; and take such applications. Upon other action as may be reasonably necessary or advisable to enable each such Selling Stockholder and each such underwriter to consummate the sale or disposition in such jurisdiction or jurisdiction in which any such termination in a country, Selling Stockholder or underwriter shall have requested that the relevant provisions in Article 17.5 shall apply with respect to such countryUnregistered GMC Common Stock be sold. 7.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than the confidentiality obligations of this Agreement.

Registration Procedure. 7.1 ALVOTECH shall as soon as reasonably possible (within a maximum of [***]] months) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] months after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement with respect to such country, provided that: (a) ALVOTECH has first notified STADA in writing of such non-submission (describing the country and due date of the submission), (b) ALVOTECH granted a last grace period of [***] to rectify such failure, and (c) STADA has not done so within said grace period, except that said [***] period shall be prolonged by such reasonable period which is necessary to allow for any required additional local studies to be conducted. STADA will keep ALVOTECH informed about progress of all such applications. Upon any such termination in a country, the relevant provisions in Article 17.5 shall apply with respect to such country. 7.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than the confidentiality obligations of this Agreement.

Registration Procedure. 7.1 ALVOTECH shall as soon as reasonably possible (within a maximum of [***]) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate Whenever required under this Agreement with respect ---------------------- to such countryeffect the registration of any Registrable Securities, provided thatthe Company shall, as expeditiously as is reasonably possible: (a) ALVOTECH has first notified STADA Prepare and file with the SEC such amendments and supplements to such registration statement and the prospectus used in writing connection with such registration statement as may be required by the rules, regulations or instructions applicable to the registration form utilized by the Company or by the Securities Act or rules and regulations otherwise necessary to keep the registration statement effective for a period of not less than twelve months (or such non-submission (describing shorter period which will terminate when all Registrable Securities covered by such registration statement have been sold or withdrawn); and cause the country prospectus as so supplemented to be filed pursuant to Rule 424 under the Securities Act; and due date comply with the provisions of the submission),Securities Act and the Exchange Act of 1934 with respect to the disposition of all securities covered by such registration statement during the applicable period in accordance with the intended methods of disposition by the selling Holders thereof set forth in such registration statement or supplement to the prospectus. (b) ALVOTECH granted Furnish to the Holders of the Registrable Securities covered by such registration statement such number of copies of a last grace period prospectus, including a preliminary prospectus, in conformity with the requirements of [***] the Securities Act, and such other documents as they may reasonably request in order to rectify such failure, andfacilitate the disposition of the Registrable Securities owned by them. (c) STADA has not done so within said grace period, except that said [***] period Use its best efforts to register and qualify the securities covered by such registration statement under such jurisdictions as shall be prolonged reasonably requested by the Holders, provided that the Company has no obligation to qualify Registrable Securities where such qualification would cause any unreasonable delay or expenditure by the Company, but the Company may be required to file a consent to service substantially in the form of the Uniform Consent to Service of Process Form U-2. (d) In the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the managing underwriter of such offering. Each selling Holder participating in such underwriting shall also enter into and perform its obligations under such an agreement. (e) Notify each Holder of Registrable Securities covered by such reasonable period registration statement, (i) at any time when a prospectus relating thereto covered by such registration statement is required to be delivered under the Securities Act, of the happening of any event as a result of which is the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to allow make the statements therein not misleading in the light of the circumstances then existing; (ii) of the issuance by the SEC of any stop order suspending the effectiveness of the registration statement or the initiation of any proceedings for that purpose; and (iii) of the receipt by the Company of any required additional local studies notification with respect to be conducted. STADA will keep ALVOTECH informed about progress the suspension of all the qualification of the Registrable Securities for sale in any jurisdiction or the initiation or threatening of any proceeding for such applications. Upon any purpose. (f) Furnish to each Holder of Registrable Securities on the date that such termination Registrable Securities are delivered to the underwriters for sale in connection with a countryregistration pursuant to this Agreement, if such securities are being sold through underwriters, or, if such securities are not being sold through underwriters, on the relevant provisions in Article 17.5 shall apply date that the registration statement with respect to such countrysecurities becomes effective (i) an opinion, dated such date, of the counsel representing the Company for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities and (ii) a letter dated such date, from the independent certified public accountants of the Company, in form and substance as is customarily given by independent certified public accountants to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities. 7.3 STADA (g) Make every reasonable effort to obtain the withdrawal of any order suspending the effectiveness of any registration statement covering Registrable Securities. (h) Cooperate with the selling Holders of Registrable Securities and the managing underwriters, if any, to facilitate the timely preparation and delivery of certificates representing Registrable Securities to be sold and not bearing any restrictive legends; and enable such Registrable Securities to be in such denominations and registered in such names as the managing underwriters may request at least two business days prior to any sale of Registrable Securities to the underwriters. (i) Use its best efforts to cause the Registrable Securities covered by the applicable registration statement to be registered with or its Affiliates will bear approved by such other foreign governmental agencies or authorities, and the NASD or any other applicable exchange or regulatory authority, as may be necessary to enable the seller or selling Holders thereof or the underwriters, if any, to consummate the disposition of such Registrable Securities. (j) Cause all Health Authority fees Registrable Securities covered by the registration statement to be listed on each securities exchange on which similar securities issued by the Company are then listed if requested by the Holders of at least 50% of such Registrable Securities or the managing underwriters, if any. (k) Cooperate and all other reasonable external costs associated assist in any filings required to be made with all MAs obtained the NASD in the performance of any due diligence investigation by or for and/or transferred to, STADA or its Affiliates any underwriter (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which "qualified independent underwriter" that is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and retained in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft rules and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy regulations of the submitted responses will be provided NASD). (l) Make available for inspection by any seller of Registrable Securities, any underwriter participating in any disposition pursuant to STADA within [***] after submission such registration statement, and any attorney, accountant or other agent retained by any such seller or underwriter, all financial and other records, pertinent corporate documents and properties of the Company, and cause the Company's officers, directors, employees and independent accountants to supply all information reasonably requested by any such seller, underwriter, attorney, accountant or agent in case connection with such procedure was conducted by ALVOTECH on behalf registration statement. (m) Permit any holder of STADA. In the event deficiency letters received from the competent Health Authorities Registrable Securities, which holder, in the Territory require significantCompany's sole and exclusive judgment, additional Product development activities beyond the requirements might be deemed to be an underwriter or a controlling Person of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in partsCompany, to any Third Party, except participate in the preparation of such registration or comparable statement and to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on require the written consent insertion therein of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier material furnished to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than Company in writing, which in the confidentiality obligations reasonable judgment of this Agreementsuch holder and its counsel should be included.

Registration Procedure. 7.1 5.1 ALVOTECH shall as soon as reasonably possible (within a maximum of [***]] months) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 5.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] months after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement with respect to such country, provided that: (a) ALVOTECH has first notified STADA in writing of such non-submission (describing the country and due date of the submission), (b) ALVOTECH granted a last grace period of [***] month to rectify such failure, and (c) STADA has not done so within said grace period, except that said [***] months’ period shall be prolonged by such reasonable period which is necessary to allow for any required additional local studies to be conducted. STADA will keep ALVOTECH informed about progress of all such applications. Upon any such termination in a country, the relevant provisions in Article 17.5 15.5 shall apply with respect to such country. 7.3 5.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 5.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] working days (or sooner) from the receipt thereof, in case the registration procedure(s) is/are being conducted by ALVOTECH on behalf of STADA. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delay, at the latest within [***] working day from the receipt thereof. Irrespective of whether the registration procedure is conducted by ALVOTECH on behalf of STADA, by STADA itself or a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module one (1) of the Dossier prior to submission, the timely and free of charge preparation of response documents to deficiency letters from the Health Authorities in English language and in accordance with applicable guidelines. Moreover, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] working days after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 5.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than the confidentiality obligations of this Agreement.

Registration Procedure. 7.1 ALVOTECH shall SECTION 5.1. Whenever required under this Agreement to effect the registration of any Registrable Securities, the Company shall, as soon expeditiously as reasonably possible (within a maximum of [***]) after completion of the Dossier and STADA’s approval, in coordination with STADA, submit to EMA a CP for the Products in STADA’s name as Marketing Authorisation holder and with STADA’s own brand name/trademark. 7.2 In addition, ALVOTECH grants the right to STADA, STADA’s Affiliates and to consultants working on behalf of STADA or its Affiliates to register the Products, at STADA’s risk and expense in respect of countries of the Territory not covered by the CP via national procedures. STADA is entitled to decide independently whether and when to submit for national applications for the Products in such countries to obtain MAs in the name of STADA, its Affiliates and/or consultants acting on STADA’s or its Affiliates’ behalf and at STADA’s own expense. For that reason, STADA is entitled to use regulatory consultants working on behalf of STADA or its Affiliates. However, if such national applications are not submitted within [***] after receipt of the Dossier for any negligent act, fault or culpable omission by STADA or any of its Affiliates or anyone acting on any of their behalves (or such longer period as the Parties mutually agree), then, on a country by country basis, ALVOTECH shall have the right to terminate this Agreement with respect to such country, provided thatpracticable: (a) ALVOTECH has first notified STADA Prepare and file with the SEC a new Registration Statement with respect to such Registrable Securities and use its reasonable best efforts to cause such registration statement to become effective, and, except as provided in writing of Article IV, keep such non-submission (describing the country and due date of the submission),Registration Statement effective at least 90 days provided, however, that no Registration Statement need remain in effect after all Registrable Securities covered thereby have been sold. (b) ALVOTECH granted a last grace period Prepare and file with the SEC such amendments and supplements to such Registration Statement and the prospectus used in connection with such Registration Statement as may be necessary to comply with the provisions of [***] the Securities Act with respect to rectify the disposition of all securities covered by such failure, andRegistration Statement. (c) STADA has not done so within said grace periodFurnish to the Holders of Registrable Securities to be registered, except without charge, such number of copies of a prospectus, including a preliminary prospectus, and any amendment or supplement thereto as they may reasonably request and a reasonable number of copies of the then-effective Registration Statement and any post-effective amendment thereto, including financial statements and schedules, all documents incorporated therein by reference and all exhibits (including those incorporated by reference). (d) Promptly after the filing of any document that said [***] period is to be incorporated by reference into a Registration Statement or prospectus, provide copies of such document to the Holders of Registrable Securities covered thereby and any underwriter. (e) Use is reasonable best efforts to register and qualify the securities covered by such Registration Statement under such other securities or blue sky laws of such jurisdictions as shall be prolonged reasonably requested by the Holders; provided, however, that the Company shall not be required to qualify to do business or to file a general consent to service of process in any such states or jurisdictions where it would not otherwise be required to so qualify to do business or consent to service of process or subject itself to taxation in any such jurisdiction. (f) Cooperate with the Holders of Registrable Securities and each underwriter participating in the disposition of such Registrable Securities and their respective counsel in connection with any filings required to be made with the National Association of Securities Dealers, Inc. (g) In the event of any underwritten public offering, enter into and perform its obligations under an underwriting agreement, in usual and customary form, with the underwriter(s) of such offering, with such terms and conditions as the Company and the underwriter(s) may agree. Each Holder participating in such underwriting shall also enter into and perform its obligations under such an agreement. (h) Notify each Holder of Registrable Securities covered by such reasonable period Registration Statement, at any time when a prospectus relating thereto is required to be delivered under the Securities Act, of the happening of any event as a result of which is the prospectus included in such Registration Statement, as then in effect, includes an untrue statement of a material fact or omits to state a material fact required to be stated therein or necessary to allow for any required additional local studies make the statements therein not misleading in the light of the circumstances then existing. (i) Cause all Registrable Securities covered by the Registration Statements to be conductedlisted on each securities exchange or automated quotation system on which shares of the Common Shares is then listed. STADA will keep ALVOTECH informed about progress If any of all such applications. Upon any such termination in a countryshares are not so listed, the relevant provisions in Article 17.5 Company shall apply with respect cause such shares to such countrybe listed on the securities exchange or automated quotation system as may be reasonably requested by the Holders of a majority of the Registrable Securities being registered. 7.3 STADA or its Affiliates will bear all Health Authority fees and all other reasonable external costs associated with all MAs obtained by or for and/or transferred to(j) In the case of an underwritten public offering, STADA or its Affiliates (including any consultants acting on any of their behalves) unless otherwise stated in this Agreement. 7.4 ALVOTECH shall use all reasonable efforts to provide the assessment reports and all deficiency letters to STADA within [***] (or sooner) from the receipt thereof. In case STADA runs the registration procedures on its own, STADA will use all reasonable efforts to provide the deficiency letters received from any Health Authority to ALVOTECH without delayfurnish, at the latest within [***] request of any Holder requesting registration pursuant to this Agreement, on the date that such Registrable Securities re delivered to the underwriters for sale in connection with a registration pursuant to this Agreement, (A) an opinion of counsel representing the Company for the purposes of such registration, (B) a letter from independent certified public accountants of the receipt thereofCompany, in each case to be dated such date and to be in form and substance as is customarily given by counsel or independent certified public accountants, as the case may be, to underwriters in an underwritten public offering, addressed to the underwriters. (k) Permit a representative of any Holder of Registrable Securities, any underwriter participating in any disposition pursuant to such registration, and any attorney or accountant retained by such Holder or underwriter, to participate, at each person's own expense, in the preparation of the Registration Statement, and cause the Company's officers, directors and employees to supply all information reasonably requested by any such representative, underwriter, attorney or accountant in connection with such registration; provided, however, that such representatives, underwriters, attorneys or accountants enter into a confidentiality agreement, in form and substance reasonably satisfactory to the Company, prior to the release or disclosure of any such information. Irrespective Notwithstanding the foregoing, the Company may withdraw (except for a registration effected pursuant to Article IV), delay or suspend any registration or qualification of whether Registrable Securities required pursuant to this Agreement for a period not exceeding 180 days (the "Blackout Period") if the Company shall deliver to the Holder(s) written notice (the "Suspension Notice") that the Company has determined in good faith that any such registration procedure is conducted by ALVOTECH on behalf or the sale of STADAthe Registrable Securities pursuant to such registration would adversely affect an offering or contemplated offering of any securities of the Company or any other contemplated material corporate event or that there exists material nonpublic information regarding the Company, by STADA itself or provided, that the Company shall not commence a regulatory consultant working on behalf of STADA and/or its Affiliates, ALVOTECH shall provide all reasonable assistance which is required to obtain and maintain the MAs as quickly as possible. Such assistance shall be interpreted as including without limitation to provide STADA with the statements, certificates and information required to compile module Blackout Period more than one (1) time in any twelve-month period. Upon delivery of a Suspension Notice, all Registration Requests (as defined below) which may have been given prior to the Suspension Notice or during the Blackout Period shall be deemed nullified. Promptly after the Company determines in good faith that the registration of Registrable Securities or any sale of Registrable Securities pursuant to such registration would not adversely affect an offering or contemplated offering of any securities of the Dossier prior to submissionCompany or any other contemplated material corporate event or that the material nonpublic information regarding the Company that caused the Blackout Period no longer exists or is no longer nonpublic information, the timely Company shall deliver to each Holder whose registration of Registrable Securities has been affected by the Blackout Period written notice that the Blackout Period has ceased (the "Suspension Rescission Notice") and free give such Holder the opportunity to renew registration of charge preparation such Holder's Registrable Securities. For purpose of response documents determining the duration of each Blackout Period, each Blackout Period shall be deemed to deficiency letters (A) commence on the earlier of (I) the first date on which the Company delivers the first Suspension Notice with respect to the Blackout Period (the "Initial Suspension Date"), or (II) the Initial Nullification Date, as defined in the LLC Agreement, and (B) terminate on the earlier of (I) the first date on which the Company delivers a Suspension Rescission Notice with respect to the applicable Suspension Notice (the "Suspension Rescission Date"), (II) the Nullification Rescission Date, as defined in the LLC Agreement, or (III) the close of business on the 180th day following the commencement of the Blackout Period. The Company shall have no obligation to cause a suspended Registration Statement provided pursuant to Article IV to be available to the Holders following a Blackout Period unless the Company receives a written request for: (a) If the Company has determined in good faith that any such registration or the sale of the Registrable Securities pursuant to such registration would adversely affect an offering or contemplated offering of any securities of the Company or any other contemplated material corporate event or that there exists material nonpublic information regarding the Company, and the Company is prohibited from commencing a Blackout period pursuant to the final paragraph of Section 5.1 or Section 9.2(c) of the LLC Agreement (a "Post-Blackout Period Event"), then the Company shall have the right during the pendency such Post-Blackout Period Event, but not the obligation (hereinafter such right sometimes referred to as the "Rights"), to purchase the Subject Shares (as defined below) from the Health Authorities in English language and in accordance with applicable guidelines. MoreoverHolder thereof, ALVOTECH will provide the draft and final response documents to deficiency letters from Health Authorities prior to submission and with sufficient time for STADA or the regulatory consultants working on behalf of STADA and/or its Affiliates to evaluate and comment on such response documents. A copy of the submitted responses will be provided to STADA within [***] after submission in case such procedure was conducted by ALVOTECH on behalf of STADA. In the event deficiency letters received from the competent Health Authorities in the Territory require significant, additional Product development activities beyond the requirements of the relevant guidelines, then ALVOTECH and STADA shall decide in mutual consent the manner in which the information shall be generated. 7.5 STADA will use the MAs and the Dossier only according to Article 2 of this Agreement. The passing on of the Dossier or copies of it, whether in whole or in parts, to any Third Party, except to STADA’s Affiliates, Distributors, sublicencees, competent authorities or external consultants (subcontractors), is strictly prohibited. Any further use depends cash on the written consent of ALVOTECH. Once STADA is entitled to arrange for the manufacture of the Product itself or its Affiliates or sub-contract it to Third Party manufacturers, STADA may for such purpose disclose the relevant parts of the Dossier terms and subject to the relevant Third Party manufacturer subject to confidentiality obligations no less stringent than conditions and restrictions contained in this Section 5.2 if the confidentiality obligations of this Agreement.Company receives a Registration Request during the