Warehouse Lease Registration Rules

does a lease less than 11 months have to be compulsarily registred, if yes where does it say and if not where does it say so

does a lease less than 11 months have to be compulsarily registred, if yes where does it say and if not where does it say so, in andra pradesh

does andhra pradesh have a specific act with respect to lease

please proofread this for me , MANUFACTURING AND SUPPLY AGREEMENT This Manufacturing and Supply Agreement (“Agreement”) is made on [●], * (“Effective Date”) by and between- A. ORDAIN HEALTH CARE GLOBAL PRIVATE LIMITED, a company incorporated under the Companies Act, *, bearing Corporate Identification Number (CIN) U24296TN2011PTC081413, and having its registered office at Survey No *, Uthiramerur Road, Melavalampettai Village, Karunkuzhi, Maduranthakam, Chengalpattu District, Tamil Nadu – *, India (hereinafter referred to as “ORDAIN”); AND B. GLADSTONE PHARMA INDIA PRIVATE LIMITED, a company incorporated under the Companies Act, * bearing CIN U24100TN2011PTC082948 and having its registered office at Plot No. *, Flat D, Pearl Flat, Nateshnagar, 2nd Cross Street, Virugambakkam, Chennai, Tamil Nadu - *, India (hereinafter referred to as “GLADSTONE”). GLADSTONE and ORDAIN shall be jointly referred to as the “Parties” and each of them, individually, as a “Party”. WHEREAS I. The Parties have engaged in negotiations and are proposing to enter into a business relationship by virtue of which ORDAIN shall manufacture and supply the Product, as defined in Annexure A, to GLADSTONE, and GLADSTONE shall purchase the Product from ORDAIN; and II. The Parties intend to formalize such business relationship by means of the present Agreement. NOW THEREFORE, the Parties hereto agrees as follows: *. DEFINITIONS Without prejudice to other terms in capital letters expressly defined in this Agreement, the following terms in capital letters shall have the meanings specified below: *.* “Affiliate” with respect to any Party means any corporation or other business entity which directly or indirectly through one or more intermediaries controls, is controlled by, or is under common control with the Party. The term “control” means the beneficial (direct or indirect) ownership of more than fifty percent (*%) of the voting or equity interests of such corporation or other business entity, or the power or right to direct the management and affairs of its business, whether through the ownership of voting securities, by contract or otherwise. *.* “Applicable Law” means any law, statute, regulation, rule, guideline, order, and any other requirement of any government, authority, committee or Regulatory Authority, applicable to the Parties’ respective obligations under this Agreement. *.* “cGMP” means all current good manufacturing practices in effect from time to time to which a Party is subject and which are in force during the Term of this Agreement, in each case to the extent that the same are applicable to the performance by the Parties of their respective obligations under the Agreement and in the place where such obligations are performed. *.* “Confidential Information” shall have the meaning provide in Clause *. *.* “Disclosing Party” shall have the meaning provided in Clause *. *.* “Force Majeure Event” means any case of external, extraordinary, and unforeseeable circumstances beyond the reasonable control of a Party that prevents such Party from performing or timely performing its obligations hereunder, including without limitation: Government regulations, changes in law, pandemics, epidemics, declarations of local or national emergency, strikes and riots, fire, natural disasters, floods, earthquakes or acts of God. *.* “Forecasts” shall mean Initial Forecast and Updated Forecast collectively. *.* “Hidden Defects” shall have the meaning provided in Clause *. *.* “Initial Forecast” shall have the meaning provided in Clause *.*. *.* “Initial Term” shall have the meaning provided in Clause *.*. *.* “Intellectual Property Rights” means all patents, copyrights, trademarks, service marks, service names, trade names, internet domain names, e-mail addresses, applications or registration for any of the foregoing, or extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto, brand marks, brand names, trade dress, labels, logos, know-how, technical and non-technical information, trade secrets, formulae, techniques, sketches, drawings, models, inventions, designs, specifications, processes, apparatus, equipment, databases, research, experimental work, development, pharmacology and clinical data, patent, clinical, regulatory and market strategies, software programs and applications, software source documents, third-party licenses, and any similar type of titles, rights and interests and intangible assets recognized under any laws or international conventions in the Territory and worldwide as intellectual property to which rights of ownership accrue pursuant to such laws or conventions or under any applicable license or contract, whether now existing or hereafter created during the Term, together with all modifications, enhancements and improvements thereto. *.* “Lead Time” shall be as established in Annexure A. *.* “Losses” means any damages, liabilities, obligations, expenses, costs or losses, including, without limitation, reasonable legal fees and expenses, court costs, arbitration fees, penalties, fines, and amounts paid in settlement of claims. *.* “Manufacturing Facilities” shall mean ORDAIN's or its Affiliate’s manufacturing facilities, as specified in Annexure B or such other third-party facilities as may be identified by ORDAIN in writing. *.* “Marketing Authorization” means a legal document issued by the Regulatory Authority that grants the right to lawfully market and sell the Product in the Territory. *.* “Payment Terms” shall be as established in Annexure A. *.* Packaging Materials” shall have the meaning established in Clause *. *.* “Pharmacovigilance Agreement” shall have the meaning established in Clause *. *.* “Product(s)” shall be as established in Annexure A. *.* “Purchase Order” means the orders for Product placed by GLADSTONE under this Agreement. *.* “Technical Agreement” shall have the meaning established in Clause *. *.* “Raw Materials” means the active pharmaceutical ingredients, all auxiliary materials and excipients used in the manufacture of the Product. *.* “Recall” shall have the meaning established in Clause *. *.* “Receiving Party” shall have the meaning established in Clause *. *.* “Registration Dossier” or “Dossier” means ORDAIN’s registration dossier for the Product, which shall include all confidential scientific documents compiled according with CDSCO/FSSAI requirements, as required for registration of the Product in the Territory. *.* “Regulatory Authority” means the regulatory authority that regulates and has competence over the import, distribution, manufacturing, marketing, labeling, or sale of pharmaceutical products in the Territory, and over any other activities to be performed by the Parties under this Agreement. *.* “Specifications” means the ingredient list, formulation, manufacturing instructions, testing and handling requirements, labeling and packaging requirements and other directions for the manufacture and supply of the Product as approved in the Marketing Authorization. *.* “Supply Price” shall be as established in Annexure A. *.* “Territory” means India. *.* “Trademark” means the trademark, brand name and/or logo under which the Product shall be marketed in the Territory, as established in Annexure A. *.* “Updated Forecasts” shall have the meaning provided in Clause *. *.* “Visual Defect” shall have the meaning provided in Clause *. *. PURPOSE OF THE AGREEMENT *.*. Subject to the terms of this Agreement, ORDAIN shall manufacture and supply the Products to GLADSTONE and GLADSTONE shall purchase the Products from ORDAIN for commercialization by GLADSTONE in the Territory under the Trademark. *. MARKETING AUTHORIZATION *.*. The Parties acknowledge that ORDAIN or its Affiliates are the owners (or have rights over) of the Registration Dossier and the holders of the Marketing Authorization for the Product in the Territory. *.*. GLADSTONE shall have no rights over the Marketing Authorization, nor shall GLADSTONE be entitled to apply for any Marketing Authorizations for the Products without ORDAIN’ written consent. *.*. In case GLADSTONE requests any variations with regard to the Marketing Authorization, such variations shall be subject to ORDAIN’ written approval and GLADSTONE shall bear all fees and costs related to such variations. *. MANUFACTURING OF THE PRODUCT *.*. ORDAIN shall manufacture the Product either directly or through its Affiliates or any third parties, in compliance with the Registration Dossier, Specifications, cGMP and Applicable Law. *.*. ORDAIN shall source the Raw Materials, packaging and labeling materials for the manufacturing, packaging, and labeling of the Products under this Agreement. *.*. As of the Effective Date, the Product shall be manufactured at the Manufacturing Facilities. In this regard, ORDAIN shall maintain and timely renew any licenses and approvals required by Applicable Law including those in Annexure B. *.*. In case either Party decides to discontinue any of the Products, the Parties shall enter into the relevant amendment to this Agreement. *.*. ORDAIN shall keep sufficient quantities of retention samples of the Products for two complete analyses as follows: (i) Finished Product for at least * (one) year after the expiry date of the relevant batch; and (ii) Raw Materials for at least * (one) year after the expiry date of the relevant Product batches for which such Raw Materials were used. *.*. ORDAIN shall maintain records of the Products manufactured by it as per Applicable Law which may include batch manufacturing records, batch packaging records, and quantities of Raw Materials used (“Manufacturing Records”). ORDAIN shall allow GLADSTONE to inspect the Manufacturing Records upon prior written request of * (seven) days. *.*. GLADSTONE, during the Term of this Agreement, may carry out audits of the Manufacturing Facilities, provided 30 days prior written notice of such an audit is given to ORDAIN and that the audits take place during normal business hours at its own costs (the “Audit”). ORDAIN undertakes to cooperate with and reasonably assist GLADSTONE during the Audits. Audits shall be limited to maximum of * (one) every * (two) years. *.*. In the event of an inspection by the Regulatory Authorities in relation to Manufacturing Facilities and the Product, ORDAIN shall assist and file necessary responses as required. *. COMMERCIALIZATION OF THE PRODUCT *.*. GLADSTONE shall be solely liable and responsible for the sale, marketing, promotion, distribution and commercialization of the Product under the Trademark in the Territory, as well as for compliance with the Applicable Laws regarding such activities. *.* GLADSTONE has the right to commercialize the Product only within the Territory and on a non-exclusive basis. GLADSTONE shall sell the Product in the Territory on its own behalf and shall assume any credit risk before its own customers. ORDAIN shall not accept any returned Product, except in accordance with Clause *.*. *.*. GLADSTONE shall not be entitled to sell or otherwise allow the sale of the Product outside the Territory. *.*. Nothing in this Agreement shall forbid or limit ORDAIN’s right to commercialize the Product inside or outside the Territory, directly or indirectly (by means of its Affiliates or third parties) under a trademark different from the Trademark. *.*. GLADSTONE shall provide ORDAIN with the maximum retail price (MRP) of the Products and shall be responsible for compliance with Drugs Price Control Order. *. CLAIMS AND PRODUCT RECALL *.*. GLADSTONE shall visually inspect the Product within a period of ten (*) days following delivery to determine the existence of any damage or fault, imperfection or shortcoming in the quality, quantity, potency, purity of the Product that would reasonably be apparent on such visual inspection (“Visual Defect”). During the foregoing period, GLADSTONE shall notify ORDAIN in writing of the existence of any Visual Defects. *.*. Moreover, if during the Shelf Life of the Product as set forth in Annexure A, GLADSTONE detects or is notified that the Product does not comply with the Specifications and the defect cannot be considered a Visual Defect (“Hidden Defect”), GLADSTONE shall notify ORDAIN within ten (*) days following the detection or notification of such Hidden Defect. *.*. In the event of the Visual Defect or Hidden Defect, GLADSTONE shall send a written notice of rejection (“Rejection Notice”) along with a copy of its analysis report to ORDAIN. *.*. If the Parties disagree as to the existence of any Visual Defect or any Hidden Defect, the Parties shall jointly select a neutral third-party laboratory to determine the existence of the Visual Defect or Hidden Defect. In the event Parties cannot agree on selection of a neutral third-party laboratory, the decision of ORDAIN regarding the selection of the laboratory shall be final. The neutral third-party laboratory’s decision shall be binding upon both Parties and the costs associated with such steps shall be borne by the Party proven wrong by the decision of the neutral third-party laboratory. *.*. If, according to the agreement between the Parties or the decision of the neutral third-party laboratory, the Product delivered is defective due to a reason attributable to ORDAIN under this Agreement, GLADSTONE shall have the option to (i) demand its replacement by ORDAIN; or (ii) obtain from ORDAIN a refund of any amount paid by GLADSTONE for the defective Product. If, according to the decision of the third-party laboratory- (i) the Product delivered is not defective; or (ii) defective due to a reason not attributable to ORDAIN under this Agreement; then ORDAIN shall be entitled to full payment for the Products as per the terms of the invoice. *.*. Product Recall. If either Party has any reason to believe that one or more batches of the Product should be recalled or if one or more batches of the Products need to be withdrawn from the market in the Territory whether resulting from a communication from a Regulatory Authority or another competent authority or otherwise (the “Recall”), such Party shall immediately notify the other Party in writing and the Parties shall consult with each other to take all appropriate corrective actions in accordance with the Quality Agreement. The final decision about carrying out any Recall, as well as the timeline, process or methods of the Recall, shall be determined by ORDAIN. The costs of any such Recall including but not limited to packaging, transportation, analysis and distribution and/or destruction costs, if applicable shall be borne (i) by ORDAIN in case such Recall is attributable to ORDAIN’ actions or inactions as manufacturer or supplier of the Product (in particular, manufacture or supply of damaged or defective Product); or (ii) by GLADSTONE in case such Recall is attributable to GLADSTONE’s actions or inactions as promoter, seller and distributor of the Product. *. PACKAGING MATERIALS AND TRADEMARK *.*. ORDAIN shall inform GLADSTONE of the format sizes and film specifications in order for GLADSTONE to design and compose the contents of the artworks, text and colours of the leaflets, aluminum foil, and cartons (all the foregoing, the “Packaging Materials”.) Batch number, expiry date, and eventual public price will be printed according to the Specifications. The name and address of GLADSTONE shall appear on the label of the innermost container of the Product as well as every other covering in which the container is packed. Any additional or special packaging requirements that may cause extra-cost should be notified by ORDAIN and accepted by GLADSTONE in writing prior to its implementation. *.*. GLADSTONE shall be responsible for providing ORDAIN with the contents of the Packaging Materials. GLADSTONE shall approve in writing the samples of the Packaging Materials provided by ORDAIN. *.*. GLADSTONE shall designate the Trademark under which the Product shall be marketed in the Territory. GLADSTONE shall own or otherwise be entitled to use and license the Trademark. GLADSTONE hereby grants ORDAIN a royalty-free, non-exclusive license to use the Trademark on the Packaging Materials during the Term, and to the extent necessary to enable ORDAIN to manufacture, label, pack and supply the Product to GLADSTONE, and allow ORDAIN to acquire necessary licenses as may be required. *.*. GLADSTONE shall be responsible for the Trademark and the contents on the Packaging Materials. GLADSTONE shall indemnify, defend and hold harmless ORDAIN, its Affiliates, and their respective directors, officers, employees and agents from and against any claim or damage arising from (a) the correctness and accuracy of the information contained in the Packaging Materials and (b) any infringement of third-party rights, or threat thereof, due to the use of the Packaging Materials or the Trademark. *.*. GLADSTONE shall also compensate ORDAIN for any cost incurred by ORDAIN as a result of modifications to the Packaging Materials, in line with Clause *.*. *.*. GLADSTONE shall bear all cylinder costs, which shall comprise any costs arising from the printing of foil for the initial artwork on the Packaging Materials or any foil artwork modifications. *. FORECASTS *.*. The Parties shall discuss and approve an initial twelve (*) month forecast for the Products to be purchased by GLADSTONE from ORDAIN under this Agreement (the “Initial Forecast”). After the approval of the Initial Forecast, GLADSTONE shall update the Initial Forecast monthly providing successive *-month forecasts to ORDAIN (the “Updated Forecasts”). *.*. During the Term, the first six (*) months of the Initial Forecast and the Updated Forecasts shall be binding on GLADSTONE. This means that during such periods, GLADSTONE commits to place the necessary Purchase Orders in order to reach at least *% of the amounts contained in the binding part of the Initial Forecast and the Updated Forecasts; whereas the remaining six (*) (non-binding) months can be modified in the following Updated Forecasts by GLADSTONE according to market circumstances. *.*. In case an Updated Forecast exceeds the previous forecast (whether the Initial Forecast or the Updated Forecast) by less than *% (twenty per cent), ORDAIN shall use commercially reasonable efforts to meet such excess. *.*. In case an Updated Forecast exceeds the previous forecast (whether the Initial Forecast or the Updated Forecast) by *% (twenty per cent) or more, ORDAIN shall be entitled to reject the Updated Forecast. *. PURCHASE ORDERS *.*. Purchase Orders placed by GLADSTONE must meet the terms of this Agreement. ORDAIN shall be entitled to reject any Purchase Orders that do not comply with the terms of this Agreement. *.*. The amount of Product ordered under each Purchase Order shall meet the Minimum Order Quantity as stipulated in Annexure A. *.*. After receipt of any Purchase Order, ORDAIN shall have seven (*) business days to process its acceptance. The Purchase Orders shall only be binding upon ORDAIN’ written acceptance. Notwithstanding the written acceptance of the Purchase Order by ORDAIN, the Purchase Order shall be deemed to be accepted only when ORDAIN has received from GLADSTONE the written approval of the Packaging Materials and the advance payment as per Clause * (Supply Price and Payment Terms). *.*. In case that GLADSTONE requests a modification to an already accepted Purchase Order, such modification shall be subject to the approval process as set forth in Clause *.* above and the Lead Time shall be counted from the written acceptance of such modification. ORDAIN shall be entitled to invoice GLADSTONE for any costs incurred by ORDAIN due to any Purchase Order amendment. *.*. No general terms or conditions of any of the Parties shall apply to the Purchase Orders placed under this Agreement. *. INVENTORY *.*. GLADSTONE shall pay or reimburse ORDAIN for the costs (including, but not limited to, any destruction costs, if applicable) of any Raw Materials, Packaging Materials, labeling materials, in-process Products and/or finished Products, as applicable, within * (Thirty) days of an invoice being raised by ORDAIN, in the following cases: (i) If GLADSTONE does not purchase within * (six) months the Products manufactured in accordance with GLADSTONE’s forecasts or Purchase Orders; and/or (ii) In case the Products are discontinued or suspended for any reason; and/or (iii) In case of modifications to Packaging Materials; and/or (iv) Upon expiration or termination of this Agreement for any reason. *. DELIVERY *.*. ORDAIN shall deliver the Product pursuant to the Incoterm set forth in Annexure A to this Agreement and with at least the Shelf Life identified in Annexure A to this Agreement. *.*. ORDAIN shall use its best efforts to deliver the Products within the Lead Time. *.*. In the event that ORDAIN for quality reasons rejects any active pharmaceutical ingredient and/or other Raw Materials from its suppliers that could cause ORDAIN to exceed the Lead Time; the Parties shall meet and negotiate in good faith a new Lead Time. *. SUPPLY PRICE AND PAYMENT TERMS *.*. In exchange for the supply of the Products, GLADSTONE shall pay to ORDAIN the Supply Price(s) defined in Annexure A of this Agreement. ORDAIN shall send the relevant invoice to GLADSTONE. *.*. Payment shall take place by means of bank transfer, to the bank account specified by ORDAIN in writing and according to the Payment Terms established in Annexure A. Any payment arising out of this Agreement shall be made in full, without deduction of any transfer charges or banking commissions. *.*. Upon delay in payment of any invoice by GLADSTONE, ORDAIN shall be entitled to *% (eighteen per cent) interest per annum over such invoice’s value from the date invoice became due and payable till such date that the amount is paid to ORDAIN, without prejudice to any other rights to which ORDAIN may be entitled. In addition, ORDAIN will be entitled to: (i) cancel any accepted Purchase Orders; (ii) Delay the delivery of ordered Product; (iii) modify the payment conditions; and/or (iv) Set off any amounts due and payable by ORDAIN to GLADSTONE against the invoice unpaid or payment delayed by GLADSTONE including the interest component. *.*. Any withholding tax applicable under this Agreement shall be paid in accordance with the Applicable Law. Where any deduction or withholding tax is applicable, GLADSTONE shall deliver to ORDAIN, within five (*) working days after ORDAIN’s request, the original receipt of deposit of such deduction or withholding tax issued by the relevant tax authorities. In case GLADSTONE does not comply with this obligation, ORDAIN will be entitled to gross up the amount of the following invoice in an amount equal to the deduction or withholding tax not credited to the benefit of ORDAIN as a result of GLADSTONE’s non-compliance. *. CONFIDENTIALITY *.*. The proprietary technical and commercial information disclosed directly or indirectly by either Party and its Affiliates (the “Disclosing Party”) to the other Party and its Affiliates (the “Receiving Party”) in execution of this Agreement shall be hereinafter referred to as “Confidential Information”. Confidential Information may include, but not necessarily be limited to the Registration Dossier, Drug Master File, know-how, supply requirements and timing, development activities and timetables, patent information, business and marketing plans and strategies, customers, business partners, financials, etc. The Confidential Information may be disclosed hereunder in writing, orally, visually and/or in another tangible or intangible form, whether identified or not as “Confidential”, and shall include information developed materially as a result of Disclosing Party’s disclosure. *.*. Receiving Party shall not disclose Confidential Information to any third party, nor shall it use Confidential Information out of the scope of this Agreement without Disclosing Party’s prior written consent. *.*. The confidentiality obligations set forth in this Clause * will not apply to Confidential Information that is: (i) Known, or becomes generally known or available to the public, through no act or failure to act on the part of the Receiving Party; (ii) Known by the Receiving Party at the time of receiving such information as evidenced by its records; or (iii) Hereafter furnished to the Receiving Party by a third party not subject to an obligation of confidentiality to the Disclosing Party with respect to such information. *.*. In the event the Receiving Party becomes lawfully compelled to disclose any Confidential Information, the Receiving Party shall provide to the Disclosing Party prompt prior written notice so that the Disclosing Party may seek a protective order or other appropriate remedy. In the event that such protective order or other remedy is not obtained, the Receiving Party shall furnish only such portion of the Confidential Information that is legally required to be disclosed, and shall use its best efforts to ensure that confidential treatment is afforded to such disclosed portion of the Confidential Information. *.*. Receiving Party acknowledges that any unauthorized disclosure or use of Confidential Information may result in great damage for Disclosing Party. In such case, Disclosing Party shall be entitled to seek an injunction restraining such breach in addition to any other rights or remedies to which the Disclosing Party may be entitled under law or this Agreement. *. REPRESENTATIONS AND WARRANTIES *.*. Representations and warranties of ORDAIN. Without prejudice to any other representations and warranties stated in this Agreement, ORDAIN represents and warrants that: (i) ORDAIN has title, competence and full right, power and authority to enter into and execute this Agreement; and (ii) ORDAIN shall perform its activities under this Agreement in accordance with Applicable Laws. *.*. Representations and warranties of GLADSTONE. Without prejudice to any other representations and warranties stated in this Agreement, GLADSTONE represents and warrants that: (i) GLADSTONE has title, competence and full right, power and authority to enter into and execute this Agreement; (ii) GLADSTONE shall perform its activities under this Agreement in accordance with Applicable Laws; (iii) GLADSTONE owns or holds relevant rights to use and license the Trademark and neither the Trademark nor the Packaging Materials violate any third-party Intellectual Property Rights, and has undertaken a search of the Trademark in the Trade Mark Registry, the central database maintained by the drug regulator, literature and reference books on drug formulations as well as the internet and is not aware of the existence of any drug with the same or confusingly similar proposed brand name; (iv) GLADSTONE holds all necessary licenses and authorizations to market, promote, distribute and sell the Product in the Territory; and (v) GLADSTONE has read and understood the ABC book (available at www.insudpharma.com) and that it complies with the principles of the ABC book and the Applicable Laws. GLADSTONE undertakes to continue to comply with the principles of the ABC book and the Applicable Laws, shall ensure that its own personnel and agents operating in relation with this Agreement receive, read, understand and comply with the ABC book and the Applicable Laws and shall ensure that all its financial transactions are fully and accurately documented and fully and accurately booked. GLADSTONE warrants that all the information provided to ORDAIN regarding the ABC book is complete and accurate and undertakes to report to ORDAIN any material change to the information provided regarding the ABC book. *. LIABILITY OF THE PARTIES *.*. Liability of ORDAIN. ORDAIN shall indemnify, defend and hold harmless GLADSTONE, its Affiliates and their respective directors, officers and employees from and against any and all Losses suffered by any of them arising from third party claims which arise from: (i) Any breach by ORDAIN, its Affiliates and/or its subcontractors of any representation, undertaking, warranty or obligation of ORDAIN under this Agreement; and/or (ii) ORDAIN’, its Affiliates’ and/or its subcontractors’ negligent and/or willful actions or omissions. ORDAIN shall not be subject to the obligation to indemnify, defend and hold harmless under this Clause *.* if the relevant Losses are attributable to GLADSTONE, its Affiliates or its subcontractors. *.*. Liability of GLADSTONE. GLADSTONE shall indemnify, defend and hold harmless ORDAIN, its Affiliates and their respective directors, officers and employees, from and against any and all Losses suffered by any of them arising from third party claims which arise from: (i) Any breach by GLADSTONE, its Affiliates and/or its subcontractors of any representation, undertaking, warranty or obligation of GLADSTONE under this Agreement; and/or (ii) GLADSTONE’s, its Affiliates’ and/or its subcontractors’ negligent and/or willful actions or omissions; and/or (iii) GLADSTONE’s, its Affiliates’ and/or its subcontractors’ activities under this Agreement, including but not limited to the sale, promotion, commercialization, marketing and distribution of the Products in the Territory; and/or (iv) The use of, or any declaration in relation to, the Trademark and/or the Packaging Materials, including but not limited to any third-party claims of violation or infringement of Intellectual Property Rights, or any threat thereof; and/or (v) ORDAIN’s inability to perform the services included in this Agreement due to reasons related to the Trademark. *.*. Indirect losses. In no event shall either Party be liable for special, indirect, incidental, exemplary, punitive or consequential damages, loss of profit or loss of business opportunity of any nature whatsoever, suffered by the other Party in connection with this Agreement. Notwithstanding the foregoing, nothing in this Agreement shall operate to exclude, restrict or limit either Party´s liability for (i) willful intent or gross negligence, or (ii) any other liability which may not be excluded or limited under Applicable Law. *.*. Indemnification Procedure. (i) Any Party seeking to be indemnified hereunder (the “Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”) in writing of any claim threatened or commenced by a third party against the Indemnified Party regarding which the Indemnified Party seeks to be indemnified hereunder (“Third-Party Claims”). (ii) The Indemnifying Party shall assume full control and direct the defence, investigation or handling of any and all such Third-Party Claims for and on behalf of the Indemnified Party, provided, however, that the Indemnifying Party shall not settle any Third-Party Claim initiated against the Indemnified Party without the Indemnified Party’s approval, which approval as it relates to money damages only shall not to be unreasonably withheld, conditioned or delayed. (iii) Neither Party shall have the ability to settle a Third-Party Claim without the other Party’s consent if the settlement would require any admittance of fault on the part of the other Party or would require any of the Parties to be subject to an injunction or other equitable relief. (iv) The Indemnified Party shall fully cooperate with the Indemnifying Party and may participate, at the Indemnified Party’s expense in the defence of such Third-Party Claims. (v) If the Indemnifying Party refuses to assume control of the defence of any Third-Party Claim, or is silent within twenty (*) days as of Indemnified Party’s request, the Indemnified Party shall, without limitation to the Indemnifying Party’s obligations hereunder, be entitled to contest, settle or pay the amount of the Third-Party Claim, and the Indemnifying Party shall be bound by the results obtained by the Indemnified Party with respect to the Third- Party Claim. *. INSURANCE Each Party shall procure and maintain at its own expense at all times during the Term and for a period of five (*) years thereafter appropriate insurance coverage, including, without limitation, commercial general liability and product liability insurance, with respect to its activities hereunder, which is consistent with normal business practices of prudent companies having similar products (with a minimum of USD *,*,* per occurrence). Such insurance will be maintained with one or more reputable insurance carriers. Each Party shall provide the other with written evidence of such insurance upon request. Maintenance of such insurance coverage will not relieve Parties of any responsibility under this Agreement for damage in excess of insurance limits or otherwise. *. INTELLECTUAL PROPERTY RIGHTS Except for the Trademark and Packaging Materials, all Intellectual Property Rights in relation to the Product and its manufacturing process, including but not limited to all rights over the Registration Dossier, shall solely vest in ORDAIN. GLADSTONE shall not use any of ORDAIN’ Confidential Information, the Registration Dossier or ORDAIN’ Intellectual Property Rights to manufacture the Product or a similar or competing product by itself or manufacture the Product or a similar or competing product by its Affiliates or by a third party and shall refrain from challenging the validity or ownership thereof. *. INTELLECTUAL PROPERTY CLAIMS *.*. ORDAIN shall be solely responsible and liable towards third parties in respect of any claims, demands, liabilities, and/or suits filed in the country of manufacture alleging infringement of Intellectual Property Rights due to its own manufacturing activities in that country. *.*. GLADSTONE shall be solely responsible and liable toward third parties in respect of any IP Claim (as defined below) filed as a consequence of or derived from the performance of any of its activities contemplated in this Agreement, including but not limited to the sale, commercialization, distribution or promotion of the Product. *.*. In the event that any third party files, in or out of court, any claims, demands, liabilities, and/or suits against GLADSTONE, or notifies it, alleging infringement of Intellectual Property Rights as a consequence of or derived from the performance of any of the operations contemplated in this Agreement (hereinafter “IP Claims”), GLADSTONE shall defend with respect to such IP Claims and bear all costs, expenses, liabilities and/or indemnifications derived from such actions. *.*. GLADSTONE shall allow ORDAIN to decide the defense strategy, the means of proof and the appeals. GLADSTONE shall not be entitled to settle, negotiate and/or make admissions, or to start conversations to seek a settlement or a negotiation, either in or out of court, of any IP Claim without having obtained the prior written approval of ORDAIN. Any settlement proposals received by GLADSTONE shall be immediately notified to ORDAIN in writing. *.*. GLADSTONE shall immediately notify ORDAIN of any such claims, demands, liabilities, suits and/or expenses alleging infringement of Intellectual Property Rights, or threat thereof. Both Parties shall collaborate for the reasonable and necessary exchange of documentation and information available (subject to confidentiality obligations) in order to enable the other Party to take action with respect to an IP Claim. GLADSTONE shall inform ORDAIN of any update with regard to any IP Claims which GLADSTONE is a party to or is aware of on a monthly basis and shall share with ORDAIN all relevant documentation. *.*. In the event that any administrative, arbitral or court decision or because a Party’s opinion in reference to potential risks related to intellectual property issues requires GLADSTONE to refrain from commercializing or ORDAIN from manufacturing and/or supplying the Product as the case may be, such Party shall have the right to suspend the commercializing, the manufacturing and/or supplying to the extent that this suspension is deemed necessary or advisable by that Party to prevent or limit actual or possible damages, liabilities or injuries. Such suspension shall be deemed a temporary suspension of each Party’s obligations hereunder and shall not amount to a termination of this Agreement (or any of its Clauses), which shall be valid in all its terms. *. TERM *.*. This Agreement will come into effect on the Effective Date and remain in force for a period of three (*) years thereafter (the “Initial Term”) unless earlier terminated in accordance with Clause * below. *.*. Once the Initial Term has elapsed, this Agreement shall automatically be renewed for successive terms of two (*) years each, unless any Party notifies in writing to the other Party its intention not to renew this Agreement at least six (*) months before the expiry of the Initial Term or the relevant renewal in course. *.*. For the purpose of this Agreement, the Initial Term and any renewals thereof shall be jointly referred to as the “Term”. *. EARLY TERMINATION OF THE AGREEMENT *.*. Termination by either Party: Either Party shall have the right to terminate this Agreement immediately upon written notice to the other Party in any of the following cases: (i) If the other Party commits a material breach of its obligations hereunder and fails to cure such material breach within the following thirty (*) days as from the written notice issued by the non-breaching Party in this regard; and/or (ii) In case of a Force Majeure Event affecting the other Party which lasts more than six (*) months; and/or (iii) If the other Party enters into bankruptcy or winding up, becomes insolvent, has a receiver appointed over its assets by a court of competent jurisdiction, or enters into any similar financial difficulties. *.*. Termination by ORDAIN. ORDAIN shall be entitled to terminate this Agreement with immediate effect upon written notice to GLADSTONE in any of the following cases: (i) If GLADSTONE or its Affiliates are prevented, limited or restricted from promoting, commercializing and/or selling the Product in the Territory by decision of the Regulatory Authority or any other competent authority; and/or (ii) If ORDAIN or its Affiliates are prevented, limited or restricted from manufacturing or supplying the Product by decision of the Regulatory Authority or any other competent authority; and/or (iii) In case of suspension, invalidation, refusal to renew or withdrawal (or any other equivalent decision) of any authorizations, licenses and/or permits required with regard to any activities under this Agreement; and/or (iv) If GLADSTONE is subject to a change of control (the term “control” to be understood as defined in Clause *.*); and/or (v) In case of infringement, or threat of infringement, in ORDAIN’s sole opinion, of any third-party Intellectual Property Rights in relation to the manufacture, supply, storage, promotion, sale, distribution or commercialization of the Product in the Territory, including in relation to the Trademark and the Packaging Materials. *. CONSEQUENCES OF TERMINATION OF THE AGREEMENT *.*. Upon expiration or termination of this Agreement for any reason whatsoever: (i) At ORDAIN’ discretion, GLADSTONE shall purchase any Purchase Order confirmed by ORDAIN prior to the effective date of expiration or termination and pay all invoices in relation thereto. (ii) Insofar as permitted from a legal and regulatory perspective, GLADSTONE shall be entitled to distribute the remaining stocks during the Shelf Life of the Product. All stocks remaining after expiration of the Shelf Life shall be destroyed by GLADSTONE at its own costs, proof of which shall be submitted to ORDAIN. (iii) GLADSTONE shall cover the costs of any remaining Products or materials, in line with Clause *. (iv) Upon request by Disclosing Party (and at Disclosing Party’s expense), Receiving Party shall return to Disclosing Party or destroy, as directed by the Disclosing Party, any Confidential Information disclosed under this Agreement with the exception of the retention of one archival copy which shall be kept confidential and may be used solely for the purpose of monitoring compliance with the confidentiality provisions of this Agreement. *.*. Termination or expiration of this Agreement for any reason shall not entitle a Party to any post termination compensation for prospective loss of business, sales, or profits of whatever nature resulting from or incident to such termination or expiry. *.*. Expiry or termination of this Agreement for any reason shall not relieve the Parties from any liability or obligation which accrued hereunder prior to the effective date of such expiry or termination. *.*. Provisions under Clause * (Claims and Product Recall), Clause * (Confidentiality), Clause * (Representation and Warranties), Clause * (Liabilities of Parties), Clause * (Insurance), Clause * (Intellectual Property Claims), this Clause * (Consequences of termination of the Agreement), Clause * (Notices), Clause * (Dispute Resolution) and Clause * (Governing Law and Jurisdiction) shall survive expiry or termination of this Agreement for any cause. *. PHARMACOVIGILANCE AGREEMENT AND TECHNICAL AGREEMENT *.*. The Parties shall enter into a separate agreement in which the pharmacovigilance duties and responsibilities of the Parties will be specified, as soon as possible after the Effective Date and in any case before the first sale by GLADSTONE of the Product in the Territory (the “Pharmacovigilance Agreement”). *.*. The Parties shall enter into a separate agreement to define the pharmaceutical and certain operational responsibilities of each Party with regard to the quality, manufacturing, packaging and storage of the Product (the “Technical Agreement”) as soon as possible after the Effective Date and in any case before GLADSTONE places the first Purchase Order hereunder. *.*. On request by ORDAIN, GLADSTONE shall forthwith supply full, accurate and true data pertaining to pharmacovigilance duties and responsibilities, as well as any other relevant details as may be sought by ORDAIN in relation to this Agreement. *.*. In the event of any inspection by Regulatory Authorities or any communication received from it, GLADSTONE shall notify ORDAIN within maximum * (two) business days of becoming aware of such inspection or communication. *. ASSIGNMENT AND SUBCONTRACTING *.*. GLADSTONE shall not assign or subcontract, in whole or in part, its contractual position or its rights and obligations under this Agreement to any third party without the prior written authorization of ORDAIN. In the event of subcontracting authorized by ORDAIN, GLADSTONE shall be, in all cases, jointly and severally liable to ORDAIN and its Affiliates for the compliance of all obligations assumed by the subcontractor. *.*. ORDAIN shall be entitled to assign or subcontract its contractual position, rights and obligations arising from this Agreement, in whole or in part, to any third parties with the prior written consent of GLADSTONE. In the event of subcontracting, ORDAIN shall be, in all cases, jointly and severally liable to GLADSTONE and its Affiliates for the compliance with all Clauses, rights, and obligations under this Agreement assumed by the subcontractor. ORDAIN shall be entitled to subcontract or assign its contractual position, rights and obligations arising from this Agreement to its Affiliates, in which case notification to GLADSTONE shall be sufficient. *. NOTICES *.*. All notices under this Agreement shall be made in writing and delivered by e-mail, which shall be deemed to have been duly delivered and received on the date of dispatch by the sender (to the extent that no “bounce back” or similar message indicating non delivery is received), in each case, to the following addresses: *.*.*. If to ORDAIN: legal.notices@insudpharma.com *.*.*. If to GLADSTONE: [●] *.*. Either Party may change the address for notices by notifying the other Party in writing of such change in accordance with this section. *. FORCE MAJEURE *.*. Neither Party shall be liable to the other Party for the delay or failure to perform its obligations hereunder except payment obligations under Clause * (Supply Price and Payment Terms), when such failure is due to a Force Majeure Event. *.*. The affected Party shall give prompt written notice to the other Party of such Force Majeure Event and shall use commercially reasonable efforts to minimize the effects thereof. *. Dispute Resolution *.*. Any dispute or difference arising out of or in connection with this agreement, including any question regarding its existence, validity or termination, shall be referred to and finally resolved by arbitration in accordance with the Arbitration and Conciliation Act, * and any modification or reenactment thereof. *.*. The arbitration shall be administered by the Delhi International Arbitration Centre in accordance with the Arbitration Proceedings Rules of the Delhi International Arbitration Centre (“DIAC Rules”) for the time being in force unless parties decide otherwise by mutual agreement in writing at any time prior to appointment of the arbitral tribunal. The DIAC Rules are deemed to be incorporated by reference in this clause. *.*. The seat and venue of the arbitration shall be Mumbai. The arbitral tribunal shall comprise of * (one) arbitrator to be mutually appointed by the Parties. The language of the arbitration shall be English. Costs of the arbitral tribunal shall be borne equally by the Parties. The arbitral award, including any interim or partial award, shall be binding on the Parties. *. Applicable Law and Jurisdiction *.*. This Agreement and the rights and liabilities of the Parties hereunder shall be governed by and construed in accordance with the laws of India (excluding its “conflict of laws” rules). *.*. Subject to Clause *, all disputes and differences arising in connection with this Agreement shall be submitted to the exclusive jurisdiction of the Courts of Mumbai, India. *. MISCELLANEOUS, ENTIRE AGREEMENT AND INTERPRETATION *.*. Complete Agreement. This Agreement, along with all exhibits and addendums incorporated herein, including the Quality Agreement and the Safety Data Exchange Agreement, constitutes the entire agreement between the Parties relating to the subject matter contained herein and supersedes any prior agreements and understandings, whether oral or written, between the Parties. For the avoidance of doubt, neither Party’s general terms and conditions shall be applicable to the performance of the Parties under this Agreement, even if they are explicitly referenced in any document (Purchase Order or confirmation of a Purchase Order). In the event of a conflict between the terms of a Purchase Order and the terms of this Agreement, the terms of this Agreement shall prevail. *.*. Amendment. This Agreement may only be amended by a written amendment duly executed by the Parties. *.*. Waiver. No omission or delay on the part of any Party hereto to enforce at any time any of the provisions hereof shall be deemed or construed to be a waiver by the omitting Party of any such provision or of its rights hereunder nor shall any single or partial exercise of any right or remedy preclude any further or other exercise of such right or remedy. *.*. Headings. The headings of the sections or paragraphs of this Agreement are included for convenience only and shall not affect the meaning of this Agreement. *.*. Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement. *.*. Severability. In case any agreement or covenant in this Agreement is held to be invalid by a court having competent jurisdiction, the Parties shall use their commercially reasonable efforts to include a new valid clause that restores the interests of both Parties.   IN WITNESS WHEREOF, the Parties have entered into this Agreement, which is signed by its duly authorized representatives. FOR ORDAIN HEALTH CARE GLOBAL PRIVATE LIMITED Name: Designation: Date: Place: FOR GLADSTONE PHARMA INDIA PRIVATE LIMITED Name: Designation: Date: Place:   ANNEXURE A *. Product and Supply Price: Products (IIN Name) Brand Name / Trademark Presentation Supply Price Minimum Order Quantity Gabapentin IP * mg & Nortriptyline IP Gabastone NT * Stripes having * tablets of * mg each INR *.* per * tablets *,* strips Methylcobalamin IP * + Piracetam IP * mg + Ginkgo Dry Extract IP New Cholinesave Stripes having * tablets of * mg each INR *.* per * tablets *,* strips *. Parties agree that the Supply Prices will vary from time to time based on rates of Raw Materials and Packaging Material as per written notice in advance of days by ORDAIN. *. Supply Prices mentioned are exclusive of Goods & Services Tax and any applicable taxes, which shall be borne by GLADSTONE at the applicable rates for the time being in force. *. Lead Time: 90 days from date of acceptance of Purchase Order *. Shelf life: Remaining shelf life upon delivery of the Product: *% *. Place of delivery and Incoterm: Ex Works – Manufacturing Facilities (EXW) *. Payment Terms: • For the First * (Three) Purchase Orders - *% (Fifty per cent) advance on acceptance of Purchase Order. Balance *% (Fifty per cent) on the date of Product delivery. • For every subsequent Purchase Order – * (Thirty) days from the date of invoice.   ANNEXURE B Manufacturing Facilities: ORDAIN HEALTHCARE GLOBAL PRIVATE LIMITED No. *, Uthiramerur Road, Melavalampettai, Karunguzhi, Madurangakam Taluk, Chengalpattu District – *, India ORDAIN maintains the following licenses and approvals in respect of the Manufacturing Facilities / Product: *. Good Manufacturing Practices (CGMP) valid up to *.*.* *. Form * Bearing No. TN00003296 valid up to *.*.* *. Form * Bearing No. TN00003297 valid up to *.*.* *. Product endorsement copies

can you please explain the changes to me

so i'm a pharmasutical company and i need to get my drug licenced , who will i go to

Under the EPF Act, the provisions start applying to an establishment once it has twenty or more persons who are employed. If you look at the definitions, the word person is not defined. However, the word employee is defined, and that includes contractor workers. I want to understand if there are any SC judgements saying that the word persons in Section *(*)(a) refers to employees and thereby contract workers too

Manufacturing License– License issued to a business that manufactures drugs.  Sale License – License issued for the sale of drugs: – Wholesale Drug License – Retail Drug License which act governs these

Case Law**: The SC in "The Regional Provident Fund Commissioner vs. Dharamsi Morarji Chemical Co. Ltd." held that the term "employee" includes contract workers. - **Interpretation**: SC has consistently ruled that the EPF Act's provisions apply to all employees, including contract workers, to ensure social security. could you please tell me which part of the judgement reads the same

hi FLC

I NEED YOUR HELP

SCHEDULE M GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS GAZETTE OF INDIA EXTRAORDINARY, PART II-SECTION *, SUB-SECTION (i)] MINISTRY OF HEALTH AND FAMILY WELFARE (DEPARTMENT OF HEALTH) New Delhi, the * December, *, please can you refer this schedule and tell me if the company that is promoting the drug on behalf on another company , has any compliances or anything they have to take care of with the licencor company that has given the manufacturing company their premisis on a loan licence agreement

yes

so my client is the one responsible for promotion and sales of the drug , and the manufacturing company is manufacturing it through another companies factory , so here under this schedule what are the things my company that is the sales comapny needs to be careful of and comply with because they have no contractual relationship with the third company (the one giving the factory on the basis of loan licence agreement) SCHEDULE M GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS GAZETTE OF INDIA EXTRAORDINARY, PART II-SECTION *, SUB-SECTION (i)] MINISTRY OF HEALTH AND FAMILY WELFARE (DEPARTMENT OF HEALTH) New Delhi, the * December, *.

can you give me specific sections under the schedule that talk about this

Notwithstanding contained anything in sub-rule (*), these rules shall not apply up to December *, * to the manufacturers, who are presently licensed to manufacture for sale of drugs. , what does this mean pls dumb it down for me

Thanks, I've read it. My question is little more specific to where Ordain is buying drugs manufactured under loan license arrangement where it's not a party. Cipla and Glenmark have a loan license arrangement to make these drugs. Ordain is just buying it from Cipla. Are there any additional complications due to loan license arrangement only? Things like GMP, quality control, storage and transport as applicable regardless of how Cipla is manufacturing the products, whether directly or through loan license